Fluid diversion mechanism for bodily-fluid sampling

ABSTRACT

An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims priority toU.S. patent application Ser. No. 13/904,691, filed May 29, 2013,entitled “Fluid Diversion Mechanism For Bodily-Fluid Sampling,” whichclaims priority to and the benefit of U.S. Provisional Application No.61/652,887, filed May 30, 2012, entitled “Fluid Diversion Mechanism forBodily-Fluid Sampling,” both of which are hereby incorporated byreference in their entirety.

This application also claims priority to and the benefit of U.S.Provisional Application Ser. No. 61/652,887, filed May 30, 2012,entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” thedisclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND

The invention relates generally to the parenteral procurement ofbodily-fluid samples, and more particularly to devices and methods forparenterally-procuring bodily-fluid samples with reduced contaminationfrom microbes or other contaminants exterior to the bodily-fluid source,such as dermally-residing microbes.

Health care practitioners routinely perform various types of microbialtests on patients using parenterally-obtained bodily-fluids. Patientsamples (e.g., bodily-fluids) are sometimes tested for the presence ofone or more potentially undesirable microbes, such as bacteria, fungi,or yeast (e.g., Candida). Microbial testing may include incubatingpatient samples in one or more sterile vessels containing culture mediathat is conducive to microbial growth. Generally, when microbes testedfor are present in the patient sample, the microbes flourish over timein the culture medium. After a pre-determined amount of time (e.g., afew hours to several days), the culture medium can be tested for thepresence of the microbes. The presence of microbes in the culture mediumsuggests the presence of the same microbes in the patient sample which,in turn, suggests the presence of the same microbes in the bodily-fluidof the patient from which the sample was obtained. Accordingly, whenmicrobes are determined to be present in the culture medium, the patientmay be prescribed one or more antibiotics or other treatmentsspecifically designed to treat or otherwise remove the undesiredmicrobes from the patient.

Patient samples, however, can sometimes become contaminated duringprocurement. One way in which contamination of a patient sample mayoccur is by the transfer of microbes from a bodily surface (e.g.,dermally-residing microbes) dislodged during needle insertion into apatient and subsequently transferred to a culture medium with thepatient sample. The bodily surface microbes may be dislodged eitherdirectly or via dislodged tissue fragments, hair follicles, sweat glandsand other adnexal structures. The transferred microbes may thrive in theculture medium and eventually yield a positive microbial test result,thereby falsely indicating the presence of such microbes in vivo. Suchinaccurate results are a concern when attempting to diagnose or treat asuspected illness or condition. For example, false positive results frommicrobial tests may result in the patient being unnecessarily subjectedto one or more anti-microbial therapies, which may cause serious sideeffects to the patient including, for example, death, as well as producean unnecessary burden and expense to the health care system.

As such, a need exists for improved bodily-fluid transfer devices andmethods that reduce microbial contamination in bodily-fluid testsamples.

SUMMARY

Devices for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments, adevice for procuring bodily-fluid samples from a patient includes ahousing, a fluid reservoir, a flow control mechanism, and an actuator.The housing includes a proximal end portion and a distal end portion anddefines an inner volume therebetween. The housing has an inlet port thatis configured to be fluidically coupled to a patient and an outlet portthat is configured to be fluidically coupled to a sample reservoir. Thefluid reservoir is disposed within the inner volume of the housing andis configured to receive and isolate a first volume of a bodily-fluidwithdrawn from the patient. The flow control mechanism defines a firstlumen and a second lumen and is disposed in the housing for rotationalmovement from a first configuration, in which the inlet port is placedin fluid communication with the fluid reservoir such that thebodily-fluid can flow from the inlet port, through the first lumen, andto the fluid reservoir, to a second configuration, in which the inletport is placed in fluid communication with the outlet port such that thebodily-fluid can flow from the inlet, through the second lumen and tothe outlet port. The actuator is configured to create a negativepressure in the fluid reservoir when actuated by a user. The actuator isoperably coupled to the flow control mechanism and is configured torotate the flow control mechanism from the first configuration to thesecond configuration after the first volume of bodily-fluid is receivedin the fluid reservoir from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a bodily-fluid transfer deviceaccording to an embodiment.

FIG. 2 is a front view of a bodily-fluid transfer device according to anembodiment.

FIG. 3 is a perspective view of the bodily-fluid transfer device of FIG.2.

FIG. 4 is an exploded view of the bodily-fluid transfer device of FIG.2.

FIG. 5 is a perspective view of a housing included in the bodily-fluidtransfer device illustrated in FIG. 2.

FIG. 6 is a cross-sectional view of the housing illustrated in FIG. 5taken along the line X₂-X₂.

FIG. 7 is a perspective view of a diverter included in the bodily-fluidtransfer device of FIG. 2.

FIG. 8 is a cross-sectional view of the diverter illustrated in FIG. 8taken along the line X₃-X₃.

FIG. 9 is a perspective view of a flow control mechanism included in thebodily-fluid transfer device of FIG. 2.

FIG. 10 is an exploded view of an actuator mechanism included in thebodily-fluid transfer device of FIG. 2.

FIG. 11 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 2 taken along the line X₁-X₁, in a first configuration.

FIG. 12 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 2 taken along the line X₁-X₁, in a second configuration.

FIG. 13 is a front view of a bodily-fluid transfer device according toan embodiment.

FIG. 14 is a perspective view of the bodily-fluid transfer device ofFIG. 13.

FIG. 15 is an exploded view of the bodily-fluid transfer device of FIG.13.

FIG. 16 is a cross-sectional view of a housing included in thebodily-fluid transfer device of FIG. 13 taken along the line X₅-X₅ inFIG. 14.

FIG. 17 is a cross-sectional view of the bodily-fluid transfer devicetaken along the line X₄-X₄ in FIG. 14, in a first configuration.

FIG. 18 is a perspective view of the bodily-fluid transfer device ofFIG. 13, in a second configuration.

FIG. 19 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 18 taken along the line X₆-X₆.

FIG. 20 is a front view of a bodily-fluid transfer device according toan embodiment.

FIG. 21 is a perspective view of the bodily-fluid transfer device ofFIG. 20.

FIG. 22 is an exploded view of the bodily-fluid transfer device of FIG.20.

FIG. 23 is a cross-sectional view of a housing included in thebodily-fluid transfer device of FIG. 20 taken along the line X₈-X₈ inFIG. 21.

FIG. 24 is a perspective view of a first control member and a secondcontrol member included in a flow control mechanism of the bodily-fluidtransfer device of FIG. 20.

FIG. 25 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 20 taken along the line X₇-X₇ in FIG. 21, in a first configuration.

FIG. 26 is a perspective view of the bodily-fluid transfer device ofFIG. 20, in a second configuration.

FIG. 27 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 25 taken along the line X₉-X₉.

FIGS. 28 and 29 schematic illustrations of a bodily-fluid transferdevice according to an embodiment, in a first and second configuration,respectively.

FIG. 30 is a perspective view of a bodily-fluid transfer deviceaccording to an embodiment.

FIG. 31 is an exploded perspective view of the bodily-fluid transferdevice of FIG. 30.

FIG. 32 is a perspective view of a housing included in the bodily-fluidtransfer device of FIG. 30.

FIG. 33 is a cross-sectional view of the housing illustrated in FIG. 32taken along the line X₁₁-X₁₁.

FIG. 34 is a perspective view of a diverter included in the bodily-fluidtransfer device of FIG. 30.

FIG. 35 is a cross-sectional view of the diverter illustrated in FIG. 34taken along the line X₁₂-X₁₂.

FIG. 36 is a perspective view of a portion of a flow control mechanismincluded in the bodily-fluid transfer device of FIG. 30.

FIG. 37 is a cross-sectional view of the portion of the flow controlmechanism illustrated in FIG. 36 taken along the line X₁₃-X₁₃.

FIGS. 38-41 are cross-sectional views of the bodily-fluid transferdevice of FIG. 32 taken along the line X₁₀-X₁₀, in a first, second,third, and fourth configuration, respectively.

FIG. 42 is a perspective view of a bodily-fluid transfer deviceaccording to an embodiment.

FIG. 43 is an exploded perspective view of the bodily-fluid transferdevice of FIG. 42.

FIG. 44 is a perspective exploded view of a flow control mechanismincluded in the bodily-fluid transfer device of FIG. 42.

FIGS. 45 and 46 are cross-sectional views of the bodily-fluid transferdevice of FIG. 42 taken along the line X₁₄-X₁₄, in a first configurationand a second configuration, respectively.

FIG. 47 is a flowchart illustrating a method for parenterally procuringa bodily-fluid sample that is substantially free from microbes.

DETAILED DESCRIPTION

Devices for parenterally procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments, adevice for procuring bodily-fluid samples from a patient includes ahousing, a fluid reservoir, a flow control mechanism, and an actuator.The housing includes a proximal end portion and a distal end portion anddefines an inner volume therebetween. The housing has an inlet port thatis configured to be fluidically coupled to a patient and an outlet portthat is configured to be fluidically coupled to a sample reservoir. Thefluid reservoir is disposed within the inner volume of the housing andis configured to receive and isolate a first volume of a bodily-fluidwithdrawn from the patient. The flow control mechanism defines a firstlumen and a second lumen and is disposed in the housing for rotationalmovement from a first configuration, in which the inlet port is placedin fluid communication with the fluid reservoir such that thebodily-fluid can flow from the inlet port, through the first lumen, andto the fluid reservoir, to a second configuration, in which the inletport is placed in fluid communication with the outlet port such that thebodily-fluid can flow from the inlet, through the second lumen and tothe outlet port. The actuator is configured to create a negativepressure in the fluid reservoir when actuated by a user. The actuator isoperably coupled to the flow control mechanism and is configured torotate the flow control mechanism from the first configuration to thesecond configuration after the first volume of bodily-fluid is receivedin the fluid reservoir from the patient.

In some embodiments, a device for procuring bodily-fluid samples from apatient includes a housing, an actuator, a diverter, and a flow controlmechanism. The housing has a proximal end portion and a distal endportion and defines an inner volume therebetween. The actuator ismovably disposed in the housing. The actuator includes a sealing memberand a fluid reservoir defined, at least in part, by the sealing member.The actuator is configured to create a negative pressure in the fluidreservoir when actuated by a user. The diverter is disposed in thehousing and has an inlet port that is configured to be fluidicallycoupled to the patient, a first outlet port that is configured to befluidically coupled to the fluid reservoir, and a second outlet portthat is configured to be fluidically coupled to a sample reservoir. Theflow control mechanism defines a first lumen and a second lumen. Theflow control mechanism is disposed in the diverter and is rotatable froma first configuration, in which the inlet port is placed in fluidcommunication with the first outlet port such that bodily-fluid can flowfrom the inlet port, through the first lumen and to the first outletport, to a second configuration, in which the inlet port is placed influid communication with the second outlet port such that thebodily-fluid can flow from the inlet, through the second lumen and tothe second outlet port.

In some embodiments, a device for procuring bodily-fluid samples from apatient includes a housing, a flow control mechanism, and an actuator.The housing has a proximal end portion and a distal end portion anddefines an inner volume therebetween. The housing has an inlet portconfigured to be fluidically coupled to the patient and an outlet portconfigured to be fluidically coupled to a sample reservoir. The flowcontrol mechanism defines a first lumen and a second lumen. The flowcontrol mechanism is disposed in the housing and is rotatable between afirst configuration, in which the inlet port is placed in fluidcommunication with a fluid reservoir defined, at least in part, by thehousing such that bodily-fluid can flow from the inlet port, through thefirst lumen and to the fluid reservoir, to a second configuration, inwhich the inlet port is placed in fluid communication with the outletport such that the bodily-fluid can flow from the inlet, through thesecond lumen and to the outlet port. The actuator is movably disposed inthe housing and is operably coupled to the flow control mechanism. Theactuator is configured to create a negative pressure in the fluidreservoir when actuated by the user. The actuator is further configuredto rotate the flow control mechanism from the first configuration to thesecond configuration after a first volume of bodily-fluid is received inthe fluid reservoir from the patient.

In some embodiments, a device for procuring bodily-fluid samples from apatient includes a housing, a seal member, a fluid reservoir, a flowcontrol mechanism, and an actuator. The housing has a proximal endportion and a distal end portion and defines an inner volumetherebetween. The housing has an inlet port configured to be fluidicallycoupled to the patient. The seal member is movably disposed in the innervolume and is configured to define, at least partially, the fluidreservoir disposed in the inner volume. The fluid reservoir isconfigured to receive and isolate a first volume of bodily-fluidwithdrawn from the patient. The flow control mechanism is movablydisposed in the housing and is configured to move between a firstconfiguration, in which the bodily-fluid can flow from the inlet port,through the flow control mechanism and to the fluid reservoir, to asecond configuration, in which the fluid reservoir is fluidicallyisolated from the inlet port. The actuator is operably coupled to theseal member and the flow control mechanism. The actuator includes aspring configured to move the seal member from a first position to asecond position to create a negative pressure in the fluid reservoir.The actuator is configured to move the flow control mechanism from thefirst configuration to the second configuration after a first volume ofbodily-fluid is received in the fluid reservoir from the patient.

In some embodiments, a device for procuring bodily-fluid samples from apatient includes a housing, a flow control mechanism, and an actuator.The housing has a proximal end portion and a distal end portion anddefines an inner volume therebetween. The housing has an inlet portconfigured to be fluidically coupled to the patient and an outlet portconfigured to be fluidically coupled to a sample reservoir. The flowcontrol mechanism is disposed in the housing and includes a firstcontrol member and a second control member. The second control memberdefines a first lumen and a second lumen and is rotatably movablebetween a first configuration, in which the inlet port is placed influid communication with a fluid reservoir defined, at least in part, bythe housing such that bodily-fluid can flow from the inlet port, throughthe first lumen and to the fluid reservoir, to a second configuration,in which the inlet port is placed in fluid communication with the outletport such that the bodily-fluid can flow from the inlet, through thesecond lumen and to the outlet port. The actuator is movably disposed inthe housing and is operably coupled to the flow control mechanism. Theactuator is configured to create a negative pressure in the fluidreservoir when actuated by the user. The actuator is further configuredto rotate the second control member from the first configuration to thesecond configuration after a first volume of bodily-fluid is received inthe fluid reservoir from the patient.

In some embodiments, a device for procuring bodily-fluid samples from apatient includes a diverter, a flow control mechanism, and an actuatormechanism. The diverter defines an inlet port, a first outlet port, anda second outlet port. The first outlet port is fluidically coupled to afirst fluid reservoir and the second outlet port is fluidically coupledto a second reservoir, fluidically isolated from the first fluidreservoir. The flow control mechanism is configured to be disposed, atleast partially within the diverter. The actuator mechanism isconfigured to engage the flow control mechanism to move the flow controlmechanism between a first configuration, in which a flow of bodily-fluidcan enter the first fluid reservoir, and a second configuration, inwhich a flow of bodily-fluid can enter the second fluid reservoir.

In some embodiments, a bodily-fluid transfer device can be configured toselectively divert a first, predetermined amount of a flow of abodily-fluid to a first reservoir before permitting the flow of a secondamount of the bodily-fluid into a second reservoir. In this manner, thesecond amount of bodily-fluid can be used for diagnostic or othertesting, while the first amount of bodily-fluid, which may containmicrobes from a bodily surface, is isolated from the bodily-fluid to betested. The first amount of bodily-fluid can be subsequently used fordifferent types of testing (e.g., CBC, other blood chemistry tests) orcan be simply sequestered.

In some embodiments, a bodily-fluid transfer device is configured toautomatically move from a first configuration to a second configuration,for example, without requiring an input or other action by a health carepractitioner. In some embodiments, the bodily-fluid transfer deviceprevents bodily-fluid from flowing or otherwise being introduced into asecond reservoir before at least a first amount of bodily-fluid (e.g., apredetermined amount) is first introduced into a first reservoir.

In some embodiments, a method for procuring a bodily-fluid sample usinga parenteral sampling device that has a needle with a lumen and a fluidreservoir fluidically coupled to the needle includes inserting theneedle of the device into a patient. The method includes establishingfluid communication between the needle and the fluid reservoir. Anactuator is moved a first distance to create a negative pressure in thefluid reservoir to withdraw a predetermined volume of the bodily-fluid.The actuator is moved a second distance to engage a flow controlmechanism and rotate the flow control mechanism from a firstconfiguration to a second configuration. The first configuration isoperable in allowing bodily-fluid to flow through a first flow path fromthe needle to the fluid reservoir and the second configuration isoperable in allowing bodily-fluid to flow through a second flow pathfrom the needle to a sample reservoir.

As used in this specification, “bodily-fluid” can include any fluidobtained from a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serousfluid, pleural fluid, amniotic fluid, and the like, or any combinationthereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used herein, the words “proximal” and “distal” refer to the directioncloser to and away from, respectively, a user who would place the deviceinto contact with a patient. Thus, for example, the end of a devicefirst touching the body of the patient would be the distal end, whilethe opposite end of the device (e.g., the end of the device beingmanipulated by the user) would be the proximal end of the device.

As used herein, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. Thus, forexample, the term “an engagement surface” is intended to mean a singlesurface or multiple surfaces unless explicitly expressed otherwise.

FIG. 1 is a schematic illustration of a portion of a bodily-fluidtransfer device 100, according to an embodiment. Generally, thebodily-fluid transfer device 100 (also referred to herein as “fluidtransfer device” or “transfer device”) is configured to permit thewithdrawal of bodily-fluid from a patient such that a first portion oramount of the withdrawn fluid is diverted away from a second portion oramount of the withdrawn fluid that is to be used as a biological sample,such as for testing for the purpose of medical diagnosis and/ortreatment. In other words, the transfer device 100 is configured totransfer a first, predetermined amount of a bodily-fluid to a firstcollection reservoir and a second amount of bodily-fluid to one or morebodily-fluid collection reservoirs fluidically isolated from the firstcollection reservoir, as described in more detail herein.

The transfer device 100 includes a diverter 120, a first reservoir 170,and a second reservoir 180, different from the first reservoir 170. Thediverter 120 includes an inlet port 122 and two or more outlet ports,such as a first outlet port 124 and a second outlet port 126 shown inFIG. 1. The inlet port 122 is configured to be fluidically coupled to amedical device defining a pathway P for withdrawing and/or conveying thebodily-fluid from the patient to the transfer device 100. For example,the inlet port 122 can be fluidically coupled to a needle or otherlumen-containing device (e.g., flexible sterile tubing). In this manner,the diverter 120 can receive the bodily-fluid from the patient via theneedle or other lumen-containing device.

The first outlet port 124 of the diverter 120 is configured to befluidically coupled to the first reservoir 170. In some embodiments, thefirst reservoir 170 is monolithically formed with the first outlet port124 and/or a portion of the diverter 120. In other embodiments, thefirst reservoir 170 can be mechanically and fluidically coupled to thediverter 120 via an adhesive, a resistance fit, a mechanical fastener,any number of mating recesses, a threaded coupling, and/or any othersuitable coupling or combination thereof. Similarly stated, the firstreservoir 170 can be physically (e.g., mechanically) coupled to thediverter 120 such that an interior volume defined by the first reservoir170 is in fluid communication with the first outlet port 120 of thediverter 120. In still other embodiments, the first reservoir 170 can beoperably coupled to the first outlet port 124 of the diverter 120 via anintervening structure (not shown in FIG. 1), such as a flexible steriletubing. More particularly, the intervening structure can define a lumenconfigured to place the first reservoir 170 in fluid communication withthe first outlet port 124.

The first reservoir 170 is configured to receive and contain the first,predetermined amount of the bodily-fluid. In some embodiments, the firstreservoir 170 is configured to contain the first amount of thebodily-fluid such that the first amount is fluidically isolated from asecond amount of the bodily-fluid (different from the first amount ofbodily-fluid) that is subsequently withdrawn from the patient. The firstreservoir 170 can be any suitable reservoir for containing abodily-fluid, such as a pre-sample reservoir described in detail in U.S.Pat. No. 8,197,420 (“the '420 Patent”), the disclosure of which isincorporated herein by reference in its entirety. As used in thisspecification, the terms “first, predetermined amount” and “firstamount” describe an amount of bodily-fluid configured to be received orcontained by the first reservoir 170. Furthermore, while the term “firstamount” does not explicitly describe a predetermined amount, it shouldbe understood that the first amount is the first, predetermined amountunless explicitly described differently.

The second outlet port 126 of the diverter 120 is configured to befluidically coupled to the second reservoir 180. In some embodiments,the second reservoir 180 is monolithically formed with the second outletport 126 and/or a portion of the diverter 120. In other embodiments, thesecond reservoir 180 can be mechanically coupled to the second outletport 126 of the diverter 120 or operably coupled to the second outletport 126 via an intervening structure (not shown in FIG. 1), such asdescribed above with reference to the first reservoir 170. The secondreservoir 180 is configured to receive and contain the second amount ofthe bodily-fluid. For example, the second amount of bodily-fluid can bean amount withdrawn from the patient subsequent to withdrawal of thefirst amount. In some embodiments, the second reservoir 180 isconfigured to contain the second amount of the bodily-fluid such thatthe second amount is fluidically isolated from the first amount of thebodily-fluid.

The second reservoir 170 can be any suitable reservoir for containing abodily-fluid, including, for example, a sample reservoir as described inthe '420 Patent incorporated by reference above. As used in thisspecification, the term “second amount” describes an amount ofbodily-fluid configured to be received or contained by the secondreservoir 180. In some embodiments, the second amount can be anysuitable amount of bodily-fluid and need not be predetermined. In otherembodiments, the second amount received and contained by the secondreservoir 180 is a second predetermined amount.

In some embodiments, the first reservoir 170 and the second reservoir180 can be coupled to (or formed with) the diverter 120 in a similarmanner. In other embodiments, the first reservoir 170 and the secondreservoir need not be similarly coupled to the diverter 120. Forexample, in some embodiments, the first reservoir 170 can bemonolithically formed with the diverter 120 (e.g., the first outlet port124) and the second reservoir 180 can be operably coupled to thediverter 120 (e.g., the second outlet port 126) via an interveningstructure, such as a flexible sterile tubing.

As shown in FIG. 1, the transfer device 100 further includes an actuator140 and a flow control mechanism 130 defining a first channel 138 and asecond channel 139. In some embodiments, the actuator 140 can beincluded in or otherwise operably coupled to the diverter 120. In thismanner, the actuator 140 can be configured to control a movement of theflow control mechanism 130 (e.g., between a first configuration and asecond configuration). For example, the actuator 140 can be movablebetween a first position corresponding to the first configuration of theflow control mechanism 130, and a second position, different from thefirst position, corresponding to the second configuration of the flowcontrol mechanism 130. In some embodiments, the actuator 140 isconfigured for uni-directional movement. For example, the actuator 140can be moved from its first position to its second position, but cannotbe moved from its second position to its first position. In this manner,the flow control mechanism 130 is prevented from being moved to itssecond configuration before its first configuration, thus requiring thatthe first amount of the bodily-fluid be directed to the first reservoir170 and not the second reservoir 180.

The flow control mechanism 130 is configured such that when in the firstconfiguration, the first channel 138 fluidically couples the inlet port122 to the first outlet port 124 and when in the second configuration,the second channel 139 fluidically couples the inlet portion 122 to thesecond outlet port 126. In some embodiments, the actuator 140 is coupledto the flow control mechanism 130 and is configured to move the flowcontrol mechanism 130 in a translational motion between the firstconfiguration and the second configuration. For example, in someembodiments, the flow control mechanism 130 can be in the firstconfiguration when the flow control mechanism 130 is in a distalposition relative to the transfer device 100. In such embodiments, theactuator 140 can be actuated to move the flow control device 130 in theproximal direction to a proximal position relative to the transferdevice 100, thereby placing the flow control mechanism 130 in the secondconfiguration. In other embodiments, the actuator 140 can be actuated tomove the flow control mechanism 130 in a rotational motion between thefirst configuration and the second configuration.

Accordingly, when the flow control mechanism 130 is in the firstconfiguration, the second outlet port 126 is fluidically isolated fromthe inlet port 122. Similarly, when the flow control mechanism 130 is inthe second configuration, the first outlet port 124 is fluidicallyisolated from the inlet port 122. In this manner, the flow controlmechanism 130 can direct, or divert the first amount of the bodily-fluidto the first reservoir 170 via the first outlet port 124 when the flowcontrol mechanism 130 is in the first configuration and can direct, ordivert the second amount of the bodily-fluid to the second reservoir 180via the second outlet port 126 when the flow control mechanism 130 is inthe second configuration.

In some embodiments, at least a portion of the actuator 140 can beoperably coupled to the first reservoir 170. In this manner, theactuator 140 (or at least the portion of the actuator 140) can beconfigured to cause a vacuum within the first reservoir 170, therebyinitiating flow of the bodily-fluid through the transfer device 100 andinto the first reservoir 170 when the diverter 120 is in its firstconfiguration. The actuator 140 can include any suitable mechanism foractuating the transfer device 100 (e.g., at least the flow controlmechanism 130), such as, for example, a rotating disc, a plunger, aslide, a dial, a button, and/or any other suitable mechanism orcombination thereof. Examples of suitable actuators are described inmore detail herein with reference to specific embodiments.

In some embodiments, the diverter 120 is configured such that the firstamount of bodily-fluid need be conveyed to the first reservoir 170before the diverter 120 will permit the flow of the second amount ofbodily-fluid to be conveyed through the diverter 120 to the secondreservoir 180. In this manner, the diverter 120 can be characterized asrequiring compliance by a health care practitioner regarding thecollection of the first, predetermined amount (e.g., a pre-sample) priorto a collection of the second amount (e.g., a sample) of bodily-fluid.Similarly stated, the diverter 120 can be configured to prevent a healthcare practitioner from collecting the second amount, or the sample, ofbodily-fluid into the second reservoir 180 without first diverting thefirst amount, or pre-sample, of bodily-fluid to the first reservoir 170.In this manner, the health care practitioner is prevented from including(whether intentionally or unintentionally) the first amount ofbodily-fluid, which is more likely to contain bodily surface microbesand/or other undesirable external contaminants that are notrepresentative of the in vivo conditions of a patient's bodily-fluidsystem, in the bodily-fluid sample to be used for analysis. Theforced-compliance aspect of the diverter 120 is described in more detailherein with reference to specific embodiments.

In some embodiments, the diverter 120 is configured to automatically(i.e., without requiring an input or other action by a health carepractitioner or other operator of the transfer device 100) fluidicallyisolate the inlet port 122 from the first outlet port 124. For example,the diverter 120 can be configured such that the flow control mechanism130 will automatically fluidically isolate the first outlet port 124from the inlet port 122 when the first reservoir 170 has received thefirst, predetermined amount of bodily-fluid. As such, additional flow ofbodily-fluid in excess of the first amount into the first reservoir 170is prevented. In some embodiments, the diverter 120 is configured suchthat the flow control mechanism 130 automatically moves from its firstconfiguration to its second configuration after the first amount ofbodily-fluid is conveyed to the first reservoir 170.

In some embodiments, the actuator 140 can have a third position,different from the first and second positions, which corresponds to athird configuration of the flow control mechanism 130. When in the thirdconfiguration, the flow control mechanism 130 can fluidically isolatethe inlet port 122 from both the first outlet port 124 and the secondoutlet port 126 simultaneously. Therefore, when the flow controlmechanism 130 is in its third configuration, flow of bodily-fluid fromthe inlet port 122 to either the first reservoir 170 or the secondreservoir 180 is prevented. In use, for example, the actuator 140 can beactuated to place the flow control mechanism 130 in the firstconfiguration such that a bodily-fluid can flow from the inlet port 122to the first reservoir 170, then moved to the second configuration suchthat the bodily-fluid can flow from the inlet port 122 to the secondreservoir 180, then moved to the third configuration to stop the flow ofbodily-fluid into and/or through the diverter 120. In some embodiments,the flow control mechanism 130 can be moved to the third configurationbetween the first configuration and the second configuration. In someembodiments, the flow control mechanism 130 can be in the thirdconfiguration before being moved to either of the first configuration orthe second configuration.

In some embodiments, one or more portions of the transfer device 100 aredisposed within a housing (not shown in FIG. 1). For example, in someembodiments, at least a portion of one or more of the diverter 120, thefirst reservoir 170, and the actuator 140 can be disposed within thehousing. In such an embodiment, at least a portion of the actuator 140is accessible through the housing. Examples of suitable housings aredescribed in more detail herein with reference to specific embodiments.

Referring now to FIGS. 2-12, a transfer device 200 includes a housing201, a diverter 220, a flow control mechanism 230, and an actuator 240.The transfer device 200 can be any suitable shape, size, orconfiguration. For example, while shown in FIGS. 2 and 3 as beingsubstantially cylindrical, the transfer device 200 can be square,rectangular, polygonal, and/or any other non-cylindrical shape.

The housing 201 includes a proximal end portion 202 and a distal endportion 203. The distal end portion 203 includes a base 206 from which aset of walls 204 extend. More specifically, the walls 204 of the housing201 define a substantially annular shape and define an inner volume 211therebetween. The proximal end portion 202 of the housing 201 isconfigured to be open such that the inner volume 211 can receive atleast a portion of the diverter 220, a portion of the flow controlmechanism 230, and a portion of the actuator 240 (FIG. 4). Similarlystated, the housing 201 is configured to house at least the portion ofthe diverter 220, the portion of the flow control mechanism 230, and theportion of the actuator 240

The walls 204 of the housing 201 define a set of status windows 210 anda set of channels 205. The status windows 210 can be any suitable shapeor size and are configured to allow a user to visually inspect at leasta portion of the transfer device 200. While shown in FIG. 5 as includingtwo status windows 210, in other embodiments, the housing 201 can defineany number of status windows 210, such as, for example, one, three,four, or more. The channels 205 defined by the housing 201 areconfigured to extend from the distal end portion 203 and through theproximal end portion 202. Similarly stated, the channels 205 extendthrough a proximal surface of the housing 201. Said yet another way, thechannels 205 are open ended at the proximal end portion 202 of thehousing 201.

The housing 201 further includes a set of guide posts 207 and a set offlow control protrusions 208. While shown in FIGS. 5 and 6 ascylindrical protrusions, the guide posts 207 can be any suitable shapeor size and are configured to extend from the base 206 in the proximaldirection. In this manner, the guide posts 207 are configured to engagea portion of the diverter 220 and a portion of the actuator 240, asfurther described herein. The flow control protrusions 208 extend fromthe base 206 in the proximal direction and define notches 209. In thismanner, the flow control protrusions 208 are configured to selectivelyengage the flow control mechanism 230 to move the flow control mechanism230 between a first configuration and a second configuration, asdescribed in further detail herein. While only one flow controlprotrusion 208 is shown in FIGS. 5 and 6, the housing 201 is configuredto include two flow control protrusions 208. In other embodiments, thehousing 201 can include any number flow control protrusions 208 such asfor example, one, three, four, or more.

As shown in FIGS. 7 and 8, the diverter 220 includes a proximal endportion 228 and a distal end portion 229 and defines an inner volume221. The inner volume 221 is configured to receive at least a portion ofthe flow control mechanism 230, as further described herein. Theproximal end portion 228 of the diverter 220 includes a first outletport 224 and can engage a portion of the actuator 240. The distal endportion 229 includes an inlet port 222 and a second outlet port 226. Asshown in FIGS. 1 and 2, the diverter 220 is disposed within the innervolume 211 of the housing 201 such that a portion of the inlet port 222extends through a first channel 205 defined by the walls 204 of thehousing 201 and a portion of the second outlet port 226 extends througha second channel 205 opposite the first channel. While not explicitlyshown in FIGS. 2-12, the distal end portion 229 of the diverter 220 isconfigured to engage the guide posts 207 such that lateral movement ofthe diverter 220 is limited. Similarly stated, the distal end portion229 of the diverter 220 can engage the guide posts 207 of the housing201 such that the diverter 220 is substantially limited to movement inthe proximal or distal direction, relative to the housing 201, asfurther described herein.

The inlet port 222 included in the distal end portion 229 of thediverter 220 defines an inlet lumen 223. As shown in FIG. 8, the inletlumen 223 is configured to be in fluid communication with the innervolume 221. Similarly stated, the inlet lumen 223 of the inlet port 222extends through a wall defining the inner volume 221 of the diverter220. The inlet port 222 is further configured to be fluidically coupledto a medical device (not shown) defining a fluid flow pathway forwithdrawing and/or conveying the bodily-fluid from a patient to thetransfer device 200. For example, the inlet port 222 can be fluidicallycoupled to a needle or other lumen-containing device (e.g., flexiblesterile tubing). Similarly stated, the inlet lumen 223 defined by theinlet port 222 is placed in fluid communication with a lumen defined bya lumen-containing device, when the lumen-containing device is coupledto the inlet port 222. Expanding further, when the lumen-containingdevice is disposed within a portion of a body of the patient (e.g.,within a vein of the patient), the inner volume 221 of the diverter 220is placed in fluid communication with the portion of the body of thepatient.

The first outlet port 224 included in the proximal end portion 228 ofthe diverter 220 defines a first outlet lumen 225. As shown in FIG. 8,the first outlet lumen 225 is configured to be in fluid communicationwith the inner volume 221 of the diverter 220 (e.g., the first outletlumen 225 extends through the wall defining the inner volume 221).Similarly, the second outlet port 226 included in the distal end portion229 of the diverter 220 defines a second outlet lumen 227 in fluidcommunication with the inner volume 221.

As shown in FIG. 9, the flow control mechanism 230 includes a firstcontrol member 231 and a second control member 235. At least a portionof the flow control mechanism 230 is configured to be disposed withinthe inner volume 221 defined by the diverter 220. In this manner, theflow control mechanism 230 defines a circular cross-sectional shape suchthat when the flow control mechanism 230 is disposed within the innervolume 221, a portion of the flow control mechanism 230 forms a frictionfit with the walls of the diverter 220 defining the inner volume 221, asdescribed in further detail herein.

The first control member 231 includes a set of activation protrusions232 and a set of cross members 234 (only one of each is shown in FIG.9). The activation protrusions 232 are configured to engage the flowcontrol protrusion 208 of the housing 201. More specifically, theactivation protrusions 232 can be disposed within the notch 209 definedby the flow control protrusion 208. Therefore, in use, the flow controlprotrusions 208 can engage the activation protrusions 232 to move theflow control mechanism 230 between a first configuration and a secondconfiguration.

The second control member 235 defines a first lumen 238, a second lumen239, and a set of channels 237 and is configured to be disposed, atleast partially, within the first control member 231. More particularly,the first control member 231 has a first diameter D₁ and the secondcontrol member 235 has a second diameter D₂ larger than the firstdiameter D₁. Therefore, when the second control member 235 is disposedwithin the first control member 231 a portion of the second controlmember 235 extends beyond a surface of the first control member 231 thatdefines the first diameter D₁.

The channels 237 defined by the second control member 235 receive thecross members 234 of the first control member 231. The arrangement ofthe cross members 234 disposed within the channels 237 is such that thesecond control member 235 is maintained in a desired position relativeto the first control member 231. In this manner, the second controlmember 235 is configured to move concurrently with the first controlmember 231 when the flow control protrusions 208 engage the activationprotrusions 232 of the first control member 231. Similarly stated, theflow control mechanism 230 is moved between the first configuration andthe second configuration when the first control member 231 and thesecond control member 235 are moved between the first configuration andthe second configuration, respectively. Furthermore, when the flowcontrol mechanism 230 is in the first configuration, the first lumen 238is placed in fluid communication with the inlet lumen 223 defined by theinlet port 222 and the first outlet lumen 225 defined by the firstoutlet port 224. When the flow control mechanism 230 is in the secondconfiguration, the second lumen 239 is placed in fluid communicationwith the inlet lumen 223 defined by the inlet port 222 and the secondoutlet lumen 227 defined by the second outlet port 226, as described infurther detail herein.

As shown in FIG. 10, the actuator mechanism 240 includes an actuatorhousing 262, a plunger 248, a cap 255, and a spring 261. The actuatormechanism 240 is configured to move between a first configuration and asecond configuration, thereby moving the transfer device 200 between afirst configuration and a second configuration, as described in furtherdetail herein. The actuator housing 262 includes a proximal end portion263 and a distal end portion 264 and defines an inner volume 265. Theactuator housing 262 can be any suitable shape, size or configuration.For example, the actuator housing 262 can be substantially cylindricaland be configured to be disposed, at least partially, within the housing201. The inner volume 265 is configured to receive the plunger 248, thespring 261, and at least a portion of the cap 255. The plunger 248includes a proximal end portion 249 and a distal end portion 249 and aside wall 251. The distal end portion 250 is configured to receive theguide posts 207 of the housing 201, as described in further detailherein. The proximal end portion 249 includes a set of retention tabs253 and can receive a portion of the spring 261. More particularly, theretention tabs 253 included in the proximal end portion 249 of theplunger 248 are configured to engage the spring 261 to removably couplethe spring 261 to the plunger 248.

The side wall 251 of the plunger 248 define a set of notches 252configured to receive a set of seal members 254. The seal members 254can be any suitable seal members 254 such as for example, o-rings formedfrom any suitable elastomeric material. In this manner, the plunger 248is disposed within the inner volume 265 of the actuator housing 262 suchthat the seal members 254 define a friction fit with the inner walls(not shown in FIG. 10) that define the inner volume 265 of the actuatorhousing 262. Similarly stated, the seal members 254 define a fluidicseal with the inner walls of the actuator housing 262. Furthermore, theplunger 248 is disposed within the inner volume 265 such that theplunger 248 divides the inner volume 265 into a first portion 267 thatis fluidically isolated from a second portion 270 (see e.g., FIGS. 11and 12). The first portion 267 of the inner volume 265 is definedbetween a surface of the proximal end portion 263 of the actuatorhousing 262 and the proximal end portion 249 of the plunger 248. Assuch, the first portion 267 of the inner volume 265 is configuredcontain the spring 261 such that the spring 261 is in contact with thesurface of the proximal end portion 263 of the actuator housing 262 andthe proximal end portion 249 of the plunger 248.

The cap 255 can be any suitable shape or size and is configured to bedisposed, at least partially, within the inner volume 265 of theactuator housing 262. Furthermore, the cap 255 can be formed from anysuitable material. For example, in some embodiments, the cap 255 isformed from an elastomeric material such as silicone. In otherembodiments, the cap 255 can be formed from any polymeric material suchas, for example, rubber, vinyl, neoprene, or the like.

The cap 255 includes a proximal end portion 256 and a distal end portion257. The proximal end portion 256 is disposed within the inner volume265 of the actuator housing 262 such that the distal end portion 250 ofthe plunger 248 and the proximal end portion 256 of the cap defines thesecond portion 270 of the inner volume (referred to henceforth as “firstreservoir”) of the inner volume 265. Expanding further, the proximal endportion 256 of the cap 255 is configured to define a friction fit withthe inner walls (not shown in FIG. 10) that define the inner volume 265.Similarly stated, the proximal end portion 254 defines a fluidic sealwith the inner walls of the actuator housing 262. Therefore, the fluidicseal defined by the actuator housing 262 and the plunger 248 and thefluidic seal defined by the actuator housing 262 and the proximal endportion 256 of the cap 255 fluidically isolate the fluid reservoir 270from a portion outside of the fluid reservoir 270 (i.e., the secondportion of the inner volume 265).

The distal end portion 257 of the cap 255 includes a set of notches 260configured to receive a set of protrusions 266 of the actuator housing262 when the proximal end portion 256 is disposed within the innervolume 265. The arrangement of the notches 260 defined by the cap 255and the protrusions 266 of the actuator housing 262 is such that theprotrusions 266 form a friction fit with the walls defining the notches260. In this manner, the protrusions 266 engage the walls defining thenotches 260 to maintain the cap 255 in a desired position relative tothe actuator housing 262 when the proximal end portion 256 is disposedwithin the inner volume 265. Moreover, the actuator mechanism 240 andthe diverter 220 are disposed within the housing 201 such that thedistal end portion 257 of the cap 255 is in contact with the proximalend portion 228 of the diverter 220, as described in further detailherein.

The cap 255 further defines an inlet port 258 and a set of guide postports 259. The inlet port 258 is configured to receive a portion of thefirst outlet port 224 included in the diverter 220. More specifically,the inlet port 258 receives the first outlet port 224 such that theinlet port 258 form a fluidic seal with an outer surface of the firstoutlet port 224. Similarly, the guide post ports 259 receive a portionof the guide posts 207 of the housing 201 such that the guide post ports259 form a fluidic seal with an outer surface of the guide posts 207. Inthis manner, a portion of the guide posts 207 and a portion of the firstoutlet port 224 are disposed within the fluid reservoir 270 defined bythe actuator housing 262. Furthermore, with the portion of the firstoutlet port 224 disposed within the fluid reservoir 270, the fluidreservoir 270 (i.e., the second portion of the inner volume 265) is influid communication with the first outlet lumen 225, as described infurther detail herein.

In some embodiments, the transfer device 200 can be stored in a storageconfiguration in which the second control member 235 of the flow controlmechanism 230 fluidically isolates the inlet port 222, the first outletport 224, and the second outlet port 226 from the inner volume 221defined by the diverter 220. In such embodiments, first lumen 238 andthe second lumen 239 are fluidically isolated from the inlet lumen 223,the first outlet lumen 225, and the second outlet lumen 227.Furthermore, the friction fit defined by the second control member 235and the walls of the diverter 220 defining the inner volume 221 maintainthe flow control mechanism 230 in the storage configuration until theflow control mechanism 230 is moved from the storage configuration.

In use, a user can engage the transfer device 200 to couple the inletport 222 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle or, as an additionalexample, surgical tubing coupleable with a Luer-Lok-type connection thatallows for mating to an indwelling catheter or hub or other generalvascular access device(s)/product(s). With the inlet port 222 coupled tothe lumen-defining device the inlet lumen 223 is placed in fluidcommunication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet lumen 223 is in fluid communication with the portion of thebody of the patient. In a similar manner, the second outlet port 226 canbe coupled to an external fluid reservoir (not shown). The externalfluid reservoir can be any suitable reservoir. For example, in someembodiments, the external fluid reservoir can be a BacT/ALERT® SN or aBacT/ALERT® FA, manufactured by BIOMERIEUX, INC.

With the inlet port 222 coupled to the lumen-defining device and thesecond outlet port 226 coupled to the external fluid reservoir, a usercan place the transfer device 200 in the first configuration by applyingan activation force to the actuator mechanism 240, thereby moving atleast a portion of the actuator mechanism 240, the diverter 220, and theflow control mechanism 230 in the distal direction towards the firstconfiguration, as shown by the arrow AA in FIG. 11. More specificallyand as described above, the distal end portion 250 of the plunger 248engages the guide posts 207 of the housing 201. The arrangement of theplunger 248 and the guide posts 207 is such that as the user applies theactivation force to the actuator mechanism 240, the position of theplunger 248, relative to the housing 201, is maintained. Therefore, theactivation force applied by the user moves the actuator housing 262, thecap 255, the diverter 220, and the flow control mechanism 230 in thedirection of the arrow AA, but not the plunger 248. Thus, the distalmovement of the actuator housing 262 is such that a portion of theactivation force is configured to compress the spring 261, and as such,the height of the second portion 267 of the inner volume is reduced. Thecompression of the spring 261 is such that the spring 261 exerts areaction force (e.g., a force of expansion) in response to the portionof the activation force compressing the spring 261. Similarly stated,the spring 261 is configured return to an expanded configuration whenthe activation force is removed.

The distal movement of the actuator housing 262 relative to the plunger248 is such that the height of the fluid reservoir 270 is increased.With the fluid reservoir 270 being fluidically isolated (as describedabove) the increase in the height (i.e., the increase in volume)produces a negative pressure within the fluid reservoir 270.Furthermore, as the actuator mechanism 240 is moved from the storageconfiguration toward the first configuration, the flow controlprotrusions 208 engage the activation protrusions 232 (not shown in FIG.11) included in the first control member 231 to move the flow controlmechanism 230 toward the first configuration, as indicated by the arrowBB. Thus, when the flow control mechanism 230 is moved to the firstconfiguration, the first lumen 238 defined by the second control member235 is placed in fluid communication with the inlet lumen 223 defined bythe inlet port 222 and the first outlet lumen 225 defined by the firstoutlet port 224.

As shown by the arrow CC, the inlet lumen 223 of the inlet port 222, thefirst lumen 238 of the second control member 235, and the first outletlumen 225 of the first outlet port 224 define a fluid flow path suchthat the fluid reservoir 270 defined by the actuator housing 262 is influid communication with the inlet port 222. Furthermore, with the inletport 222 coupled to the lumen-defining device the fluid reservoir 270 ofthe actuator housing 262 is placed in fluid communication with theportion of the patient (e.g., the vein). The negative pressure withinthe fluid reservoir 270 is such that the negative pressure differentialintroduces a suction force within the portion of the patient. In thismanner, a bodily-fluid is drawn into the fluid reservoir 270 of theactuator housing 262. In some embodiments, the bodily-fluid can containundesirable microbes such as, for example, dermally-residing microbes.

In some embodiments, the magnitude of the suction force can be modulatedby increasing or decreasing the amount of activation force applied tothe actuator mechanism 240. Excess suction force can, in some cases,collapse a patient's vein thereby cutting off sample flow. Once a veinis collapsed, one or more additional venipunctures may be required toaccess a non-collapsed vein. Excess suction force may also causehemolysis at the needle tip within the vein due to excessive negativepressure. Thus, in some embodiments, it can be desirable to limit theamount of suction force (i.e., modulate the negative pressure during ablood draw) introduced to a vein to reduce, minimize, or even eliminatevein collapse and/or one potential source of hemolysis. In suchembodiments, the user can reduce the amount of force applied to theactuator mechanism 240. In this manner, the reaction force exerted bythe expansion of the spring 261 (e.g., as described above) is sufficientto overcome a portion of the activation force applied by the user. Thus,the spring 261 can expand to move the plunger 248 and the housing 201 inthe distal direction, relative to the actuator housing 262, the cap 255,the diverter 220, and the flow control mechanism 230. The distalmovement of the plunger 248 and housing 201 is such that the flowcontrol protrusions 208 engage the activation protrusions 232 of theflow control mechanism 230 to move the flow control mechanism 230towards the storage configuration. The rotation of the flow controlmechanism 230 (e.g., in a direction opposite the arrow BB) reduces thesize of the fluid pathway (e.g., an inner diameter) between the inletlumen 223 and the first lumen 238 and the first outlet port 225 and thefirst lumen 238, thereby reducing the suction force introduced into thevein of the patient.

With the desired amount of bodily-fluid transferred to the fluidreservoir 270 defined by the actuator housing 262, a user can engage thetransfer device 200 to move the transfer device 200 from the firstconfiguration to the second configuration, wherein a flow ofbodily-fluid is transferred to the external reservoir (e.g., such asthose described above). In some embodiments, the desired amount ofbodily-fluid transferred to the actuator housing 262 is a predeterminedamount of fluid. For example, in some embodiments, the transfer device200 can be configured to transfer bodily-fluid until the pressure withinthe fluid reservoir 270 defined by the actuator housing 262 is inequilibrium with the pressure of the portion of the body in which thelumen-defining device is disposed (e.g., the vein). In such embodiments,the equalizing of the pressure between the second portion 176 of theinner volume 265 and the portion of the body stops the flow of thebodily-fluid into the actuator housing 262. In some embodiments, thepredetermined amount of bodily-fluid (e.g., volume) is at least equal tothe combined volume of the inlet lumen 223, the first lumen 238, thefirst outlet lumen 225, and the lumen-defining device.

As shown in FIG. 12, the transfer device 200 can be moved from the firstconfiguration to the second configuration by further moving the actuatormechanism 240 in the distal direction, as indicated by the arrow DD.Expanding further, the user can apply an activation force to theactuator mechanism 240 such that the actuator housing 262, the cap 255,the diverter 220, and the flow control mechanism 230 move in the distaldirection. With the desired amount of the bodily-fluid disposed withinthe fluid reservoir 270 the volume of the fluid reservoir 270 isconfigured to remain constant as the actuator housing 262 and the cap255 move relative to the plunger 248. Similarly stated, the pressure ofthe fluid reservoir 270 is configured to remain substantially unchangedas the transfer device 200 is moved from the first configuration to thesecond configuration.

As the actuator mechanism 240 is moved from the first configurationtoward the second configuration, the flow control protrusions 208 engagethe activation protrusions 232 (not shown in FIG. 12) included in thefirst control member 231 to move the flow control mechanism 230 towardthe second configuration, as indicated by the arrow EE. Thus, when theflow control mechanism 230 is moved to the second configuration, thesecond lumen 239 defined by the second control member 235 is placed influid communication with the inlet lumen 223 defined by the inlet port222 and the second outlet lumen 227 defined by the second outlet port226.

As shown by the arrow FF, the inlet lumen 223 of the inlet port 222, thesecond lumen 239 of the second control member 235, and the second outletlumen 227 of the second outlet port 226 define a fluid flow path suchthat the external reservoir (not shown in FIG. 12) is in fluidcommunication with the inlet port 222 and, therefore, the portion of thepatient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid isdrawn into the external reservoir and is fluidically isolated from thefirst, predetermined amount of bodily-fluid contained within the fluidreservoir 270 defined by the actuator housing 262. In this manner, thebodily-fluid contained in the external reservoir is substantially freefrom microbes generally found outside of the portion of the patient(e.g., dermally residing microbes, microbes within a lumen defined bythe transfer device 200, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe(s)). With thedesired amount of bodily-fluid contained in the external fluidreservoir, the user can remove the activation force from the actuatormechanism 240 (e.g., remove the portion of the hand engaging theactuator mechanism 240). With the removal of the activation force, thespring 261 exerts the force of expansion (described above) to move thetransfer device 200 from the second configuration to the storageconfiguration. With the transfer device 200 in the storageconfiguration, the first outlet port 224 is fluidically isolated fromthe first lumen 238 and/or the second lumen 239 of the flow controlmechanism 230. Thus, the bodily-fluid contained within the actuatorhousing 262 is fluidically isolated from a volume outside the actuatorhousing 262 and the external reservoir can be decoupled from thetransfer device 200. In addition, the bodily-fluid contained within theactuator housing 262 is isolated from the patient and the healthcareworker, and can be safely disposed of (e.g., in a biohazard materialscontainer) in a “closed” device.

While the transfer device 200 is shown and described in FIGS. 2-12 asdisposing the diverter 220 within the housing 201, in some embodiments,a transfer device can include a diverter and housing that aremonolithically formed. For example, FIGS. 13-19 illustrate a transferdevice 300 according to an embodiment. FIGS. 13 and 14 illustrate thetransfer device 300 in a first configuration. The transfer device 300includes a housing 301, having a diverter 320 and defining a fluidreservoir 370, a flow control mechanism 330, and an actuator 340.

The housing 301 includes a proximal end portion 302 and a distal endportion 303. The distal end portion 303 of the housing 301 includes aset of walls 304 that define a channel 305 configured to receive adistal portion 342 of the actuator 340. The walls 304 can be configuredto define the channel 305 with any suitable shape, size, orconfiguration. For example as shown in FIG. 16, the walls 304 can beconfigured to further define a slot 319 in the channel 305 configured toreceive an activation extension 346 included in the actuator 340 (FIG.15). Similarly stated, the slot 319 can be configured to receive theactivation extension 346 included in the distal portion 342 of theactuator 340, disposed within the channel 305, such that the activationextension 346 can pass through the walls 304 and be disposedsubstantially outside the channel 305, as described in further detailherein.

The walls 304 of the distal end portion 303 of the housing 301 alsoinclude a recessed surface 315 and a stop 313 (FIGS. 15 and 16). Thestop 313 defines a proximal boundary of the channel 305 that can limitthe movement of the actuator 340 within the channel 305. Furthermore,the stop 313 defines a passageway 314 configured to receive a portion ofthe actuator 340 such that the portion of the actuator 340 can extend inthe proximal direction beyond the stop 313, as further described herein.The recessed surface 315 is configured to be a flat surface from whichthe diverter 320 can extend. Similarly stated, the diverter 320 is a setof walls configured to extend perpendicularly from the recessed surface315. In this manner, the diverter 320 receives at least a portion of theflow control mechanism 340, as described in further detail herein. Whileshown and described as extending perpendicularly from the recessedsurface 315, in other embodiments, the diverter 320 can extend from therecessed surface 315 at any suitable angular orientation.

As shown in FIG. 15, the proximal end portion 302 of the housing 301includes a set of walls 318 that extend from the stop 313 in theproximal direction. In this manner, the walls 318 define a tubular shapesubstantially enclosed at the distal end by the stop 313 and open at theproximal end. The walls 318 define a slot 312 and an inner volume 311configured to receive a proximal end portion 341 of the actuator 340. Asfurther described herein, the proximal end portion 302 of the housing301, the stop 313, and the proximal end portion 341 of the actuator 340define a fluid reservoir 370 configured to receive and/or contain abodily fluid.

As shown in FIG. 16, the diverter 320 includes an inlet port 322, afirst outlet port 324, and a second outlet port 326, and defines aninner volume 321. The inner volume 321 is configured to receive at leasta portion of the flow control mechanism 330, as further describedherein. The inlet port 322 of the diverter 320 defines an inlet lumen323. The inlet lumen 323 is configured to be in fluid communication withthe inner volume 321. Similarly stated, the inlet lumen 323 of the inletport 322 extends through a wall defining the inner volume 321 of thediverter 320.

The inlet port 322 is further configured to be fluidically coupled to amedical device (not shown) defining a fluid flow pathway for withdrawingand/or conveying the bodily-fluid from a patient to the transfer device300. For example, the inlet port 322 can be fluidically coupled to aneedle or other lumen-containing device (e.g., flexible sterile tubing).Similarly stated, the inlet lumen 323 defined by the inlet port 322 isplaced in fluid communication with a lumen defined by a lumen-containingdevice, when the lumen-containing device is coupled to the inlet port322. Expanding further, when the lumen-containing device is disposedwithin a portion of a body of the patient (e.g., within a vein of thepatient), the inner volume 321 of the diverter 320 is placed in fluidcommunication with the portion of the body of the patient.

The first outlet port 324 of the diverter 320 defines a first outletlumen 325. The first outlet lumen 325 is configured to be in fluidcommunication with the inner volume 321 of the diverter 320 and thefluid reservoir 370 (described above). Similarly stated, the firstoutlet lumen 325 is configured to extend through the wall defining theinner volume 321 and through a portion of the stop 313 defining thefluid reservoir 370, thereby placing the fluid reservoir 370 in fluidcommunication with the inner volume 321. The second outlet port 326 ofthe diverter 320 defines a second outlet lumen 327 and can be coupled toan external fluid reservoir. In this manner, the second outlet lumen 327can extend through the wall defining the inner volume 321 to be in fluidcommunication with the inner volume 321 and can be fluidically coupledto the external reservoir to place the external fluid reservoir in fluidcommunication with the inner volume 321.

As shown in FIG. 15, the flow control mechanism 330 includes a firstcontrol member 331 and a second control member 335. At least a portionof the flow control mechanism 330 is configured to be disposed withinthe inner volume 321 defined by the diverter 320. In this manner, theflow control mechanism 330 defines a circular cross-sectional shape suchthat when the flow control mechanism 330 is disposed within the innervolume 321, a portion of the flow control mechanism 330 forms a frictionfit with the walls of the diverter 320 defining the inner volume 321, asdescribed in further detail herein.

The first control member 331 includes a set of activation protrusions332 configured to engage a set of protrusion 347 included in theactivation extension 346 of the actuator 340. Therefore, in use, theactuator 340 can engage the activation protrusions 332 to move the flowcontrol mechanism 330 between a first configuration and a secondconfiguration. The second control member 335 defines a first lumen 338and a second lumen 339 and can be formed from any suitable material. Forexample, in some embodiments, the second control member 335 is formedfrom silicone. In other embodiments, the second control member 335 canbe any suitable elastomer configured to deform when disposed within theinner volume 321 of the diverter. Expanding further, the second controlmember 335 has a diameter larger than the diameter of the inner volume321. In the manner, the diameter of the second control member 335 isreduced when the second control member 335 is disposed within the innervolume 321. Thus, the outer surface of the second control member 335forms a friction fit with the inner surface of the walls defining theinner volume 321.

The second control member 335 is configured to be coupled to the firstcontrol member 331. For example, in some embodiments, the first controlmember 331 can be coupled to the second control member 335 via amechanical fastener and/or adhesive. In other embodiments, the firstcontrol member 331 and the second control member 335 can be coupled inany suitable manner. In this manner, the second control member 335 isconfigured to move concurrently with the first control member 331 whenthe activation extension 347 of the actuator 340 engages the activationprotrusions 332 of the first control member 331. Similarly stated, theflow control mechanism 330 is moved between the first configuration andthe second configuration when the first control member 331 and thesecond control member 335 are moved between the first configuration andthe second configuration, respectively. Furthermore, when the flowcontrol mechanism 330 is in the first configuration, the first lumen 338is placed in fluid communication with the inlet lumen 323 defined by theinlet port 322 and the first outlet lumen 325 defined by the firstoutlet port 324. When the flow control mechanism 330 is in the secondconfiguration, the second lumen 339 is placed in fluid communicationwith the inlet lumen 323 defined by the inlet port 322 and the secondoutlet lumen 327 defined by the second outlet port 326, as described infurther detail herein.

As described above, the actuator mechanism 340 includes the proximal endportion 341, the distal end portion 342, and an actuator arm 343therebetween. The actuator mechanism 340 is configured to move between afirst configuration and a second configuration, thereby moving thetransfer device 300 between a first configuration and a secondconfiguration, as described in further detail herein. The proximal endportion 341 includes a plunger 348 configured to be disposed within theinner volume 311 of the housing 301. More particularly, the plunger 348includes a seal member 354 configured to define a friction fit with theinner surface of the walls 318 defining the inner volume 311. Similarlystated, the seal member 354 defines a fluidic seal with the innersurface of the walls 318 defining the inner volume 311 such that aportion of the inner volume 311 proximal of the seal member 354 isfluidically isolated from a portion of the inner volume 311 distal ofthe seal member 354.

The actuator arm 343 is configured to extend from the proximal endportion 341 of the actuator 340 through the passageway 314 defined bythe stop 313. Therefore, as described above, the distal end portion 342of the actuator 340 is disposed on a distal side of the stop 313. Morespecifically, the distal end portion 342 includes an engagement portion344 and the activation portion 346. The engagement portion 344 and atleast a portion (e.g., a distal portion) of the actuator arm 343 areconfigured to be disposed within the channel 305 such that theactivation portion 346 can extend through the slot 319, as describedabove. In this manner, a user can engage the engagement portion 344 tomove the actuator 340 in a distal direction between a firstconfiguration and a second configuration, as further described herein.

In some embodiments, the transfer device 300 can be stored in the firstconfiguration in which the first lumen 338 of the second control member335 is in fluid communication with the inlet port 322 and the firstoutlet port 324. In such embodiments, the friction fit defined by thesecond control member 335 and the walls of the diverter 320 defining theinner volume 321 maintain the flow control mechanism 330 in the firstconfiguration until the actuator 340 moves the flow control mechanism330 to the second configuration.

In use, a user can engage the transfer device 300 to couple the inletport 322 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. With the inlet port 322coupled to the lumen-defining device the inlet lumen 323 is placed influid communication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet lumen 323 is in fluid communication with the portion of thebody of the patient. In a similar manner, the second outlet port 326 canbe coupled to an external fluid reservoir (not shown). The externalfluid reservoir can be any suitable reservoir. For example, in someembodiments, the external fluid reservoir can be a BacT/ALERT® SN or aBacT/ALERT® FA blood culture collection bottle with media specificallydesigned to facilitate the growth of certain types of microbes (e.g.,aerobic media/broth and/or aerobic media/broth), manufactured byBIOMERIEUX, INC.

With the inlet port 322 coupled to the lumen-defining device and thesecond outlet port 326 coupled to the external fluid reservoir, a usercan begin the transfer of a bodily-fluid by applying an activation forceto the engagement portion 344 of the actuator 340, thereby moving theactuator 340 the distal direction, as shown by the arrow GG in FIG. 17.More specifically and as described above, the plunger 348 engages theinner surface of the walls 318 defining the inner volume 311 such thatthe volume of the fluid reservoir 370 is increased (e.g., as defined bythe plunger 348, the walls 318 of the housing 301 and the stop 313).With the fluid reservoir 370 being fluidically isolated (as describedabove) from a volume on the proximal side of the seal member 354, theincrease in the volume of the fluid reservoir 370 produces a negativepressure within the fluid reservoir 370. Moreover, with the flow controlmechanism 330 in the first configuration, negative pressure differentialintroduces a suction force within the first lumen 338, the inlet lumen323, and the first outlet lumen 325.

As shown by the arrow HH, the inlet lumen 323 of the inlet port 322, thefirst lumen 338 of the second control member 335, and the first outletlumen 325 of the first outlet port 324 define a fluid flow path suchthat the second portion 376 of the inner volume 373 defined by the fluidreservoir 370 is in fluid communication with the inlet port 322.Furthermore, with the inlet port 322 coupled to the lumen-definingdevice the fluid reservoir 370 is in fluid communication with theportion of the patient (e.g., the vein) and at least a portion of thesuction force is introduced to the portion of the patient. In thismanner, a bodily-fluid is drawn into the fluid reservoir 370. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes dislodged during the insertionof the lumen-defining device.

In some embodiments, the magnitude of the suction force can be modulatedby moving the actuator 340 in the proximal or distal direction. Forexample, in some embodiments, it can be desirable to limit the amount ofsuction force introduced to a vein. In such embodiments, the user canmove the actuator 340 in the proximal direction (e.g., the direction ofthe arrow II in FIG. 18) such the activation extension 346 can engagethe protrusions 332 of the first control member 331. In this manner, theprotrusions 347 included in the activation extension 346 can mesh withthe protrusions 332 of the first control member 331 to rotate the firstcontrol member 331 in the direction of the arrow JJ. The rotation of theflow control mechanism 330 (e.g., in a direction opposite the arrow JJ)reduces the size of the fluid pathway (e.g., an inner diameter) betweenthe inlet lumen 323 and the first lumen 338 and the first outlet port325 and the first lumen 338, thereby reducing the suction forceintroduced into the vein of the patient.

With the desired amount of bodily-fluid transferred to the fluidreservoir 370, a user can engage the transfer device 300 to move thetransfer device 300 from the first configuration to the secondconfiguration, wherein a flow of bodily-fluid is transferred to theexternal reservoir (e.g., such as those described above). In someembodiments, the desired amount of bodily-fluid transferred to the fluidreservoir 370 is a predetermined amount of fluid. For example, in someembodiments, the transfer device 300 can be configured to transferbodily-fluid until the pressure within the fluid reservoir 370 isequilibrium with the pressure of the portion of the body in which thelumen-defining device is disposed (e.g., the vein). In such embodiments,the equalizing of the pressure between the fluid reservoir 370 and theportion of the body stops the flow of the bodily-fluid into the fluidreservoir 370. In some embodiments, the predetermined amount ofbodily-fluid (e.g., volume) is at least equal to the combined volume ofthe inlet lumen 323, the first lumen 338, the first outlet lumen 325,and the lumen-defining device.

As shown in FIG. 18, the transfer device 300 can be moved from the firstconfiguration to the second configuration by further moving the actuatormechanism 340 in the distal direction, as indicated by the arrow II. Asthe actuator mechanism 340 is moved from the first configuration towardthe second configuration, the protrusions 347 of the activationextension 346 further engage the activation protrusions 332 included inthe first control member 331 to move the flow control mechanism 330 tothe second configuration, as indicated by the arrow KK in FIG. 19. Inthis manner, the flow control mechanism 330 is moved to the secondconfiguration, and the first lumen 238 is fluidically isolated from theinlet lumen 223 and the first outlet lumen 225. In addition, the secondlumen 339 defined by the second control member 335 is placed in fluidcommunication with the inlet lumen 323 defined by the inlet port 322 andthe second outlet lumen 327 defined by the second outlet port 326.

As shown by the arrow LL, the inlet lumen 323 of the inlet port 322, thesecond lumen 339 of the second control member 335, and the second outletlumen 327 of the second outlet port 326 define a fluid flow path suchthat the external reservoir (not shown in FIG. 19) is in fluidcommunication with the inlet port 322 and, therefore, the portion of thepatient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid isdrawn into the external reservoir and is fluidically isolated from thefirst, predetermined amount of bodily-fluid contained within the fluidreservoir 370.

The bodily-fluid contained in the external reservoir is substantiallyfree from microbes generally found outside of the portion of the patient(e.g., dermally residing microbes, microbes within a lumen defined bythe transfer device 300, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe). In someembodiments, with the desired amount of bodily-fluid contained in theexternal fluid reservoir, the user can further move the actuator 340 inthe proximal direction to place the transfer device 300 in a thirdconfiguration. In such embodiments, the actuator 340 can be moved in theproximal direction such that the engagement portion 344 and/or theactivation extension 346 contact the stop 313, thereby limiting furtherproximal movement of the actuator 340. In this configuration, theactuator 340 can place the flow control mechanism 330 in a thirdconfiguration configured to fluidically isolate the first lumen 338 andthe second lumen 339 from the inlet lumen 323, the first outlet lumen325, and the second outlet lumen 327. Thus, the bodily-fluid containedwithin the fluid reservoir 370 is fluidically isolated from a volumeoutside the fluid reservoir 370 and the external reservoir can bedecoupled from the transfer device 300.

While the transfer device 300 is shown and described in FIGS. 13-19 asbeing configured to actuated by continual user influence (e.g., the usermanually moves the actuator 340 in the proximal direction), in someembodiments, a transfer device need not require continual userinfluence. For example, FIGS. 20-26 illustrate a transfer device 400according to an embodiment. FIGS. 20 and 21 illustrate the transferdevice 400 in a first configuration. The transfer device 400 includes ahousing 401, having a diverter 420 and defining a fluid reservoir 470, aflow control mechanism 430, and an actuator mechanism 440.

The housing 401 includes a proximal end portion 402 and a distal endportion 403. The distal end portion 403 of the housing 401 includes aset of walls 404 having a recessed portion 415 and a stop 413 (FIGS. 22and 23). The stop 413 defines a distal boundary of the recessed portion415 and defines a passageway 414. The passageway 414 is configured toreceive an activation extension 346 included in the actuator mechanism440 such that the activation extension 346 extends through the stop 413,as further described herein. The recessed portion 415 includes asubstantially flat surface from which the diverter 420 can extend (FIG.22). Similarly stated, the diverter 420 is a set of walls configured toextend perpendicularly from the surface of the recessed portion 415. Inthis manner, the diverter 420 receives at least a portion of the flowcontrol mechanism 430, as described in further detail herein. Whileshown and described as extending perpendicularly from the surface of therecessed portion 415, in other embodiments, the diverter 420 can extendfrom the surface at any suitable angular orientation.

The proximal end portion 402 of the housing 401 includes a set of walls418 that extend from the stop 413 in the proximal direction. In thismanner, the walls 418 define a tubular shape substantially enclosed atthe distal end by the stop 413 and open at the proximal end. Theproximal end portion 402 of the housing 401 can be formed from anysuitable material. For example, in some embodiments, the proximal endportion 402 can be formed from a relatively flexible material. In suchembodiments, the proximal end portion 402 can be configured to deform(e.g., bend, compress, or otherwise reconfigure) under a given force, asdescribed in further detail herein. As shown in FIG. 23, the walls 418include shoulder 416 and retention tabs 417 and define an inner volume411 configured to receive a portion of the actuator mechanism 440. Asfurther described herein, the proximal end portion 402 of the housing401, the stop 413, and a portion of the actuator mechanism 440 define afluid reservoir 470 configured to receive and/or contain a bodily fluid.

As shown in FIG. 23, the diverter 420 includes an inlet port 422, afirst outlet port 424, and a second outlet port 426, and defines aninner volume 421. The inner volume 421 is configured to receive at leasta portion of the flow control mechanism 430, as further describedherein. The inlet port 422 of the diverter 420 defines an inlet lumen423. The inlet lumen 423 is configured to be in fluid communication withthe inner volume 421. Similarly stated, the inlet lumen 423 of the inletport 422 extends through a wall defining the inner volume 421 of thediverter 420.

The inlet port 422 is further configured to be fluidically coupled to amedical device (not shown) defining a fluid flow pathway for withdrawingand/or conveying the bodily-fluid from a patient to the transfer device400. For example, the inlet port 422 can be fluidically coupled to aneedle or other lumen-containing device (e.g., flexible sterile tubing).Similarly stated, the inlet lumen 423 defined by the inlet port 422 isplaced in fluid communication with a lumen defined by a lumen-containingdevice, when the lumen-containing device is coupled to the inlet port422. Expanding further, when the lumen-containing device is disposedwithin a portion of a body of the patient (e.g., within a vein of thepatient), the inner volume 421 of the diverter 420 is placed in fluidcommunication with the portion of the body of the patient.

The first outlet port 424 of the diverter 420 defines a first outletlumen 425. The first outlet lumen 425 is configured to be in fluidcommunication with the inner volume 421 of the diverter 420 and thefluid reservoir 470 (described above). Similarly stated, the firstoutlet lumen 425 is configured to extend through the wall defining theinner volume 421 and through a portion of the stop 413 defining thefluid reservoir 470, thereby placing the fluid reservoir 470 in fluidcommunication with the inner volume 421. The second outlet port 426 ofthe diverter 420 defines a second outlet lumen 427 and is configured tobe coupled to an external fluid reservoir. In this manner, the secondoutlet lumen 427 can extend through the wall defining the inner volume421 to be in fluid communication with the inner volume 421 and can befluidically coupled to the external reservoir to place the externalfluid reservoir in fluid communication with the inner volume 421.

As shown in FIG. 24, the flow control mechanism 430 includes a firstcontrol member 431 and a second control member 435. At least a portionof the flow control mechanism 430 is configured to be disposed withinthe inner volume 421 defined by the diverter 420. In this manner, theflow control mechanism 430 defines a circular cross-sectional shape suchthat when the flow control mechanism 430 is disposed within the innervolume 421, a portion of the flow control mechanism 430 forms a frictionfit with the walls of the diverter 420 defining the inner volume 421, asdescribed in further detail herein.

The first control member 431 includes an activation protrusion 432 andengagement protrusions 433. The activation protrusion 432 is configuredto engage a protrusion 447 included in the activation extension 446 ofthe actuator mechanism 440. Therefore, in use, the actuator mechanism440 can engage the activation protrusion 432 to move the flow controlmechanism 430 between a first configuration and a second configuration.The second control member 435 defines a first lumen 438, a second lumen439, and a set of grooves 437. The second control member 435 can beformed from any suitable material such as, for example, silicone. Inother embodiments, the second control member 435 can be any suitableelastomer configured to deform when disposed within the inner volume 421of the diverter. Expanding further, the second control member 435 has adiameter larger than the diameter of the inner volume 421. In themanner, the diameter of the second control member 435 is reduced whenthe second control member 435 is disposed within the inner volume 421.Thus, the outer surface of the second control member 435 forms afriction fit with the inner surface of the walls defining the innervolume 421.

The grooves 437 defined by the second control member 435 are configuredto receive the engagement protrusions 433. In this manner, the firstcontrol member 431 can selectively engage the second control member 435such that the second control member 435 is moved concurrently with thefirst control member 431 when the activation extension 447 of theactuator mechanism 440 engages the activation protrusion 432 of thefirst control member 431. Similarly stated, the flow control mechanism430 is moved between the first configuration and the secondconfiguration when the first control member 431 and the second controlmember 435 are moved between the first configuration and the secondconfiguration, respectively. Furthermore, when the flow controlmechanism 430 is in the first configuration, the first lumen 438 isplaced in fluid communication with the inlet lumen 423 defined by theinlet port 422 and the first outlet lumen 425 defined by the firstoutlet port 424. When the flow control mechanism 430 is in the secondconfiguration, the second lumen 439 is placed in fluid communicationwith the inlet lumen 423 defined by the inlet port 422 and the secondoutlet lumen 427 defined by the second outlet port 426, as described infurther detail herein.

As shown in FIGS. 22 and 25, the actuator mechanism 440 includes anengagement member 444, the activation extension 446, a plunger 448, anda spring 461. The engagement member 444 is configured to be coupled tothe distal end portion 403 of the housing 401. In this manner, thehousing 401 and the engagement member 444 house the flow controlmechanism 430 and at least a portion of the diverter 420. The engagementmember 444 includes a throttling button 445. The throttling button 445is configured such that when engaged by a user, the throttling button445 interacts with the flow control mechanism 430 to modulate themovement of the flow control mechanism 440, as described in furtherdetail herein.

The plunger 448 includes a proximal end portion 449 and a distal endportion 450 and is configured to be disposed within the inner volume 411defined by the housing 401. The proximal end portion 449 of the plunger448 is configured to selectively engage the retention protrusions 417included in the housing 401. The plunger 448 further includes a sealingmember 454 disposed at the distal end portion 450. The seal member 454is configured to define a friction fit with the inner surface of thewalls 418 defining the inner volume 411. Similarly stated, the sealmember 454 defines a fluidic seal with the inner surface of the walls418 defining the inner volume 411 such that a portion of the innervolume 411 proximal of the seal member 454 is fluidically isolated froma portion of the inner volume 411 distal of the seal member 454.

The spring 461 includes a proximal end portion 462 and a distal endportion 463 and is configured to circumscribe the plunger 448. Similarlystated, the plunger 448 is disposed within the spring 461 when thespring 461 and the plunger 448 are disposed within the housing 401.Furthermore, when disposed within the inner volume 411, the distal endportion 463 of the spring 461 is configured to engage the shoulder 416of the housing 401 and the proximal end portion 462 is configured toengage the proximal end portion 449 of the plunger 448. In this manner,the spring 461, when urged to move from a first (compressed)configuration to a second (expanded) configuration, is configured tomove the plunger 448 in the proximal direction, as described in furtherdetail herein.

The activation extension 446 can be any suitable size, shape, orconfiguration. For example, as shown in FIG. 22, the activationextension 446 can be a flexible tether formed from, for example, nylon.In this manner, the activation extension 446 can be substantiallyflexible in a lateral direction and substantially rigid in an axialdirection. Similarly stated, in some embodiments, the activationextension 446 is configured to bend, twist, conform, and/or otherwisereconfigure without stretching. Said yet another way, the length of theactivation extension 446 is configured to remain substantially unchangedas the activation extension 446 is bent or otherwise reconfigured.

The activation extension 446 is configured to be coupled to the distalend portion 450 of the plunger 448. More specifically, a proximal endportion of the activation extension 446 is disposed within the innervolume 411 of the housing 401 and is coupled to the plunger 448 and adistal end portion of the activation extension 446 passes through thestop 413 and is disposed within the recessed portion 415 of the housing401. In this manner, the activation extension 446 is configured engagethe activation protrusion 432 of the first control member 431 to movethe flow control mechanism 430 between the first configuration and thesecond configuration, as described in further detail herein.

In some embodiments, the transfer device 400 can be stored in a storageconfiguration in which the second control member 435 of the flow controlmechanism 430 fluidically isolates the inlet port 422, the first outletport 424, and the second outlet port 426 from the inner volume 421defined by the diverter 420. In such embodiments, first lumen 438 andthe second lumen 439 are fluidically isolated from the inlet lumen 423,the first outlet lumen 425, and the second outlet lumen 427.Furthermore, the friction fit defined by the second control member 435and the walls of the diverter 420 defining the inner volume 421 maintainthe flow control mechanism 430 in the storage configuration until theflow control mechanism 430 is moved from the storage configuration.

In use, a user can engage the transfer device 400 to couple the inletport 422 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. With the inlet port 422coupled to the lumen-defining device the inlet lumen 423 is placed influid communication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet lumen 423 is in fluid communication with the portion of thebody of the patient. In a similar manner, the second outlet port 426 canbe coupled to an external fluid reservoir (not shown). The externalfluid reservoir can be any suitable reservoir. For example, in someembodiments, the external fluid reservoir can be a BacT/ALERT® SN or aBacT/ALERT® FA, manufactured by BIOMERIEUX, INC.

With the inlet port 422 coupled to the lumen-defining device and thesecond outlet port 426 coupled to the external fluid reservoir, a usercan begin a transfer of a bodily-fluid by applying an activation forceto the transfer device 400. More specifically, the user can introduce anactivation force to the proximal end portion 402 of the housing 401 bysqueezing, for example, the sides of the proximal end portion 402 suchthat the proximal end portion 402 deforms in response to the activationforce, as described above. Thus, the proximal end portion 402 is urged(in response to the activation force) to reconfigure such that theretention tabs 417 are removed from contact with the proximal endportion 449 of the plunger 448. Expanding further, the retention tabs417 are configured to apply a reaction force to the proximal end portion449 of the plunger 448 in response to an expansion force exerted by thespring 461, thereby maintaining the spring 461 in the compressedconfiguration. With the retention tabs 417 removed from contact with theplunger 448 and with the distal end portion 463 of the spring 461 incontact with the shoulder 416 of the housing 401, the proximal endportion 462 of the spring 462 expands to move the plunger 448 in thedirection of the arrow MM in FIG. 25.

As described above, the plunger 448 engages the inner surface of thewalls 418 defining the inner volume 411 such that the volume of thefluid reservoir 470 is increased (e.g., as defined by the plunger 448,the walls 418 of the housing 401 and the stop 413). With the fluidreservoir 470 being fluidically isolated (as described above) from avolume on the proximal side of the seal member 454, the increase in thevolume of the fluid reservoir 470 produces a negative pressure withinthe fluid reservoir 470. Moreover, movement of the plunger 448 in theproximal direction is such that the activation extension 446 is moved inthe proximal direction. In this manner, the protrusion 447 of theactivation extension 446 engages the protrusion 432 of the first controlmember 431 to move the flow control mechanism 430 from the storageconfiguration to the first configuration, as indicated by the arrow NN.With the flow control mechanism 430 in the first configuration, thenegative pressure of the fluid reservoir 470 introduces a suction forcewithin the first lumen 438, the inlet lumen 423, and the first outletlumen 425.

As shown by the arrow OO, the inlet lumen 423 of the inlet port 422, thefirst lumen 438 of the second control member 435, and the first outletlumen 425 of the first outlet port 424 define a fluid flow path suchthat the second portion 476 of the inner volume 473 defined by the fluidreservoir 470 is in fluid communication with the inlet port 422.Furthermore, with the inlet port 422 coupled to the lumen-definingdevice the fluid reservoir 470 is in fluid communication with theportion of the patient (e.g., the vein) and at least a portion of thesuction force is introduced to the portion of the patient. In thismanner, a bodily-fluid is drawn into the fluid reservoir 470. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes dislodged during the insertionof the lumen-defining device.

In some embodiments, the rate of expansion of the spring 461 can bemodulated by engaging the throttling button 445 included in theengagement portion 444 of the actuator mechanism 440. For example, insome embodiments, it can be desirable to limit the amount of suctionforce introduced to a vein. In such embodiments, the user can exert aforce on the throttling button 445 such that the throttling button 445is moved to engage the flow control mechanism 430. In this manner, thethrottling button 445 can increase the friction between, for example,the second control member 435 and the walls defining the inner volume421 of the diverter. Thus, the increase in friction between the secondcontrol member 435 and the walls defining the inner volume 411 resistthe force exerted by the activation extension 446, thereby slowing therate of expansion of the spring. In this manner, the reduction ofpressure (e.g., the increase in negative pressure) of the fluidreservoir 470 can be controlled to maintain a desired pressuredifferential between the vein and the fluid reservoir 470 and limit thesuction force introduced to the vein.

In some embodiments, the user can depress the throttling button 445 tomaintain the transfer device 400 in the first configuration. With thedesired amount of bodily-fluid transferred to the fluid reservoir 470, auser can disengage the throttling button 445 to disengage the throttlingbutton 445 from the flow control mechanism 430. In this manner, thefriction between the second control member 435 and the walls definingthe inner volume 411 is reduced and the force of expansion exerted bythe spring is sufficient to again overcome the friction between thesecond control member 435 and the walls defining the inner volume 411.Therefore, the transfer device 400 is moved 400 from the firstconfiguration to the second configuration, wherein a flow ofbodily-fluid is transferred to the external reservoir (e.g., such asthose described above).

In some embodiments, the desired amount of bodily-fluid transferred tothe fluid reservoir 470 is a predetermined amount of fluid. For example,in some embodiments, the transfer device 400 can be configured totransfer bodily-fluid until the pressure within the fluid reservoir 470is equilibrium with the pressure of the portion of the body in which thelumen-defining device is disposed (e.g., the vein). In such embodiments,the equalizing of the pressure between the fluid reservoir 470 and theportion of the body stops the flow of the bodily-fluid into the fluidreservoir 470. In some embodiments, the predetermined amount ofbodily-fluid (e.g., volume) is at least equal to the combined volume ofthe inlet lumen 423, the first lumen 438, the first outlet lumen 425,and the lumen-defining device.

As described above, the transfer device 400 is moved from the firstconfiguration to the second configuration by further moving the plunger448 in the distal direction. As the plunger 448 is moved from the firstconfiguration toward the second configuration, the protrusions 447 ofthe activation extension 446 further engage the activation protrusions432 included in the first control member 431 to move the flow controlmechanism 430 to the second configuration, as indicated by the arrow PPin FIG. 26. In this manner, the flow control mechanism 430 is moved tothe second configuration, and the first lumen 438 is fluidicallyisolated from the inlet lumen 423 and the first outlet lumen 425. Inaddition, the second lumen 439 defined by the second control member 435is placed in fluid communication with the inlet lumen 423 defined by theinlet port 422 and the second outlet lumen 427 defined by the secondoutlet port 426.

As shown by the arrow QQ in FIG. 27, the inlet lumen 423 of the inletport 422, the second lumen 439 of the second control member 435, and thesecond outlet lumen 427 of the second outlet port 426 define a fluidflow path such that the external reservoir (not shown in FIG. 19) is influid communication with the inlet port 422 and, therefore, the portionof the patient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. In some embodiments, the user can engagethrottling button 445 to again increase the friction between the secondcontrol member 435 and the walls defining the inner volume 411. In thismanner, further expansion of the spring 461 is limited and a desiredamount of bodily-fluid can be drawn into the external reservoir suchthat the desired amount of bodily fluid is fluidically isolated from thefirst, predetermined amount of bodily-fluid contained within the fluidreservoir 470.

The bodily-fluid contained in the external reservoir is substantiallyfree from microbes generally found outside of the portion of the patient(e.g., dermally-residing microbes, microbes within a lumen defined bythe transfer device 400, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe). In someembodiments, with the desired amount of bodily-fluid contained in theexternal fluid reservoir, the user can disengage the throttling button445 such that the transfer device returns to the storage configuration.As described above, in this configuration the actuator mechanism 440 canplace the flow control mechanism 430 in a third configuration configuredto fluidically isolate the first lumen 438 and the second lumen 439 fromthe inlet lumen 423, the first outlet lumen 425, and the second outletlumen 427. Thus, the bodily-fluid contained within the fluid reservoir470 is fluidically isolated from a volume outside the fluid reservoir470 and the external reservoir can be decoupled from the transfer device400.

While the transfer device 400 is described above with reference to FIGS.20-27 as being stored in a storage configuration, in some embodiments, atransfer device can be stored in a first configuration (e.g., defining aflow path between an inlet port and a fluid reservoir). For example,FIGS. 28 and 29 illustrate a transfer device 500 according to anembodiment. In some embodiments, aspects of the transfer device 500 canbe substantially similar to corresponding aspects of the transfer device200. In this manner, details of certain aspects are not described infurther detail herein and it should be understood that such aspects aresubstantially similar in form or function to the corresponding aspects.

The transfer device 500 includes a housing 501, a diverter 520, a flowcontrol mechanism 530, and an actuator 540. The housing 501 includes aproximal end portion 502 and a distal end portion 503. The proximal endportion 502 defines an inner volume configured to receive at least aportion of the actuator mechanism 540, as described in further detailherein. The distal end portion 503 of the housing 501 includes thediverter 520. Similarly stated, the diverter 520 is monolithicallyformed with the distal end portion 503 of the housing 501. The diverter520 receives at least a portion of the flow control mechanism 530, asdescribed in further detail herein.

As shown in FIG. 28, the diverter 520 includes an inlet port 522, afirst outlet port 524, and a second outlet port 526, and defines aninner volume 521. The inner volume 521 is configured to receive at leasta portion of the flow control mechanism 530, as further describedherein. The inlet port 522 of the diverter 520 defines an inlet lumen523. The inlet lumen 523 is configured to be in fluid communication withthe inner volume 521. Similarly stated, the inlet lumen 523 of the inletport 522 extends through a wall defining the inner volume 521 of thediverter 520.

The flow control mechanism 530 includes a first control member 531 and asecond control member 535. At least a portion of the flow controlmechanism 530 is configured to be disposed within the inner volume 521defined by the diverter 520. In this manner, the flow control mechanism530 defines a circular cross-sectional shape such that when the flowcontrol mechanism 530 is disposed within the inner volume 521, a portionof the flow control mechanism 530 forms a friction fit with the walls ofthe diverter 520 defining the inner volume 521, as described in furtherdetail herein.

The first control member 53 is configured to engage an activationextension 546 of the actuator mechanism 540 and move between a firstconfiguration and a second configuration. The second control member 535defines a first lumen 538 and a second lumen 539 and is configured to becoupled to the first control member 531. Therefore, the second controlmember 535 is configured to move concurrently with the first controlmember 531 when the activation extension 546 engages the first controlmember 531. Similarly stated, the flow control mechanism 530 is movedbetween the first configuration and the second configuration when thefirst control member 531 and the second control member 535 are movedbetween the first configuration and the second configuration,respectively. Furthermore, when the flow control mechanism 530 is in thefirst configuration, the first lumen 538 is placed in fluidcommunication with the inlet lumen 523 defined by the inlet port 522 andthe first outlet lumen 525 defined by the first outlet port 524. Whenthe flow control mechanism 530 is in the second configuration, thesecond lumen 539 is placed in fluid communication with the inlet lumen523 defined by the inlet port 522 and the second outlet lumen 527defined by the second outlet port 526, as described in further detailherein.

The actuator mechanism 540 is configured to move between a firstconfiguration and a second configuration, thereby moving the transferdevice 500 between a first configuration and a second configuration, asdescribed in further detail herein. The actuator mechanism 540 includesa plunger 548 and the activation extension 546. The plunger 548 includesa proximal end portion 549, a distal end portion 550, and an engagementportion 544 and is configured to be disposed, at least partially withinthe inner volume 511 of the housing 501. The engagement portion 544 isconfigured to extend in the distal direction from the proximal endportion 549 of the plunger 548. In this manner, the engagement portion544 can be engaged by a user to move the actuator mechanism 540 betweenthe first configuration and the second configuration, as described infurther detail herein.

The distal end portion 550 of the plunger 548 includes a seal member 554configured to define a friction fit with the inner surface of the wallsdefining the inner volume 511. Similarly stated, the seal member 554defines a fluidic seal with the inner surface of the walls defining theinner volume 511 such that a portion of the inner volume 511 proximal ofthe seal member 554 is fluidically isolated from a portion of the innervolume 511 distal of the seal member 554. Furthermore, the portion ofthe inner volume 511 distal of the seal member 554 defines a fluidreservoir 570. Similarly stated, the fluid reservoir 570 defined by thewalls defining the inner volume 511 and the seal member 554 of theplunger 548.

The activation extension 546 includes a protrusion 547 configured toselectively engage the proximal end portion 549 of the plunger 548. Inthis manner, the proximal end portion 549 of the plunger 548 can movethe activation extension 546 when the plunger 548 moves from a firstconfiguration to a second configuration, as further described herein.

As described above, the transfer device 500 is stored in the firstconfiguration in which the first lumen 538 of the second control member535 is in fluid communication with the inlet port 522 and the firstoutlet port 524. In such embodiments, the friction fit defined by thesecond control member 535 and the walls of the diverter 520 defining theinner volume 521 maintain the flow control mechanism 530 in the firstconfiguration until the actuator 540 moves the flow control mechanism530 to the second configuration.

In use, a user can engage the transfer device 500 to couple the inletport 522 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. With the inlet port 522coupled to the lumen-defining device the inlet lumen 523 is placed influid communication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet lumen 523 is in fluid communication with the portion of thebody of the patient. In a similar manner, the second outlet port 526 canbe coupled to an external fluid reservoir (not shown).

With the inlet port 522 coupled to the lumen-defining device and thesecond outlet port 526 coupled to the external fluid reservoir, a usercan begin the transfer of a bodily-fluid by applying an activation forceto the engagement portion 544 of the actuator 540, thereby moving theplunger 548 in the distal direction, as shown by the arrow RR in FIG.28. More specifically and as described above, the plunger 548 engagesthe inner surface of the walls defining the inner volume 511 such thatthe volume of the fluid reservoir 570 is increased (e.g., as defined bythe plunger 548 and the housing 501). With the fluid reservoir 570 beingfluidically isolated (as described above) from a volume on the proximalside of the seal member 554, the increase in the volume of the fluidreservoir 570 produces a negative pressure within the fluid reservoir570. Moreover, with the flow control mechanism 530 in the firstconfiguration, negative pressure differential introduces a suction forcewithin the first lumen 538, the inlet lumen 523, and the first outletlumen 525.

As shown by the arrow SS, the inlet lumen 523 of the inlet port 522, thefirst lumen 538 of the second control member 535, and the first outletlumen 525 of the first outlet port 524 define a fluid flow path suchthat the second portion 576 of the inner volume 573 defined by the fluidreservoir 570 is in fluid communication with the inlet port 522.Furthermore, with the inlet port 522 coupled to the lumen-definingdevice the fluid reservoir 570 is in fluid communication with theportion of the patient (e.g., the vein) and at least a portion of thesuction force is introduced to the portion of the patient. In thismanner, a bodily-fluid is drawn into the fluid reservoir 570. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes dislodged during the insertionof the lumen-defining device.

As shown in FIG. 28, the actuator mechanism 540 is configured such thatthe proximal end portion 549 of the plunger 548 is spaced apart from theprotrusion 547 of the activation extension 546. In this manner, theplunger 548 can move in the proximal direction without engaging theprotrusion 547 of the activation extension 546. Thus, the plunger 548can move to introduce the change of the volume in the fluid reservoir570 without the activation extension 546 moving the first control member531 from the first configuration toward the second configuration.Therefore, the transfer device 500 can be stored in the firstconfiguration, as described above.

With a desired amount of bodily-fluid transferred to the fluid reservoir570, a user can move the transfer device 500 from the firstconfiguration to the second configuration, wherein a flow ofbodily-fluid is transferred to the external reservoir (e.g., such asthose described above). In some embodiments, the desired amount ofbodily-fluid transferred to the fluid reservoir 570 is a predeterminedamount of fluid. For example, in some embodiments, the transfer device500 can be configured to transfer bodily-fluid until the pressure withinthe fluid reservoir 570 is equilibrium with the pressure of the portionof the body in which the lumen-defining device is disposed (e.g., thevein). In such embodiments, the equalizing of the pressure between thefluid reservoir 570 and the portion of the body stops the flow of thebodily-fluid into the fluid reservoir 570. In some embodiments, thepredetermined amount of bodily-fluid (e.g., volume) is at least equal tothe combined volume of the inlet lumen 523, the first lumen 538, thefirst outlet lumen 525, and the lumen-defining device.

As shown in FIG. 29, the transfer device 500 can be moved from the firstconfiguration to the second configuration by further moving the actuatormechanism 540 in the distal direction, as indicated by the arrow TT. Asthe actuator mechanism 540 is moved from the first configuration towardthe second configuration, the protrusions 547 of the activationextension 546 is engaged by the proximal end portion 549 of the plunger548 such that the activation extension 546 is moved in the direction TT.Furthermore, the proximal motion of the activation extension 546 movesthe first control member 331 and places the flow control mechanism 530in the second configuration, as indicated by the arrow UU. In thismanner, the first lumen 538 is fluidically isolated from the inlet lumen523 and the first outlet lumen 525. In addition, the second lumen 539defined by the second control member 535 is placed in fluidcommunication with the inlet lumen 523 defined by the inlet port 522 andthe second outlet lumen 527 defined by the second outlet port 526.

As shown by the arrow VV, the inlet lumen 523 of the inlet port 522, thesecond lumen 539 of the second control member 535, and the second outletlumen 527 of the second outlet port 526 define a fluid flow path suchthat the external reservoir (not shown in FIGS. 28 and 29) is in fluidcommunication with the inlet port 522 and, therefore, the portion of thepatient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid isdrawn into the external reservoir and is fluidically isolated from thefirst, predetermined amount of bodily-fluid contained within the fluidreservoir 570.

The bodily-fluid contained in the external reservoir is substantiallyfree from microbes generally found outside of the portion of the patient(e.g., dermally residing microbes, microbes within a lumen defined bythe transfer device 500, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe). As describedabove, the bodily-fluid contained within the fluid reservoir 570 isfluidically isolated from a volume outside the fluid reservoir 570 andthe external reservoir can be decoupled from the transfer device 500.

While some embodiments described above include a flow control mechanismthat can be rotated to control the flow of a bodily-fluid (e.g., theflow rate) and/or to control the amount of negative pressure within afluid reservoir, in other embodiments, bodily-fluid transfer device caninclude any suitable device, mechanism, and/or assembly that cancontrol, at least partially, a flow of bodily-fluid (e.g., the flow rateof the bodily-fluid). For example, FIGS. 30-41 illustrate a transferdevice 600 according to an embodiment. The transfer device 600 includesa housing 601, a diverter 620, a flow control mechanism 630, andadjustment mechanism 685, and an actuator 640. The transfer device 600can be any suitable shape, size, or configuration. For example, thetransfer device 600 can have a shape and size that is substantiallysimilar to the transfer device 200 described above with reference toFIGS. 2-12. As such, portions of the transfer device 600 can besubstantially similar in form and/or function to corresponding portionsof the transfer device 200 of FIGS. 2-12. Thus, aspects of the transferdevice 600 are not described in further detail herein.

The housing 601 of the transfer device 600 includes a proximal endportion 602 and a distal end portion 603. The distal end portion 603includes a base 606 from which a set of walls 604 extend. The walls 604of the housing 601 define a substantially annular shape and define aninner volume 611 between the proximal end portion 602 and the distal endportion 603. The proximal end portion 602 of the housing 601 is open toreceive at least a portion of the diverter 620, a portion of the flowcontrol mechanism 630, and a portion of the actuator 640 within theinner volume 611 (see e.g., FIG. 31). The walls 604 of the housing 601define a set of status windows 610 and a set of channels 605. The statuswindows 610 and the channels 605 can be any suitable shape or size. Forexample, the status windows 610 and the channels 605 can besubstantially similar in form and function to the status windows 210 andthe channels 205 of the transfer device 200.

As shown in FIGS. 32 and 33, the housing 601 includes a set of guideposts 607 and a set of flow control protrusions 608 and defines apassageway 614. The guide posts 607 engage a portion of the diverter 620and a portion of the actuator 640, as further described herein. The flowcontrol protrusions 608 extend from the base 606 in the proximaldirection and can be arranged to selectively engage a portion of theflow control mechanism 630 to move the flow control mechanism 630between a first configuration and a second configuration, as describedin further detail herein. While only one flow control protrusion 608 isshown in FIGS. 32 and 33, the housing 601 can include, for example, twoflow control protrusions 608 that are disposed adjacent to a guide post607. As shown in FIG. 33, the passageway 614 extends through the base606 and can be arranged to receive a portion of the flow controlmechanism 630, as described in further detail herein.

As shown in FIG. 31, the actuator mechanism 640 includes the actuatorhousing 662, a plunger 648, and a cap 655. The actuator mechanism 640 isconfigured to move between a first configuration and a secondconfiguration, thereby moving the transfer device 600 between a firstconfiguration and a second configuration, as described in further detailherein. The actuator housing 662 includes a proximal end portion 663 anda distal end portion 664 and defines an inner volume 665. The innervolume 665 of the actuator housing 662 receives the plunger 648 and atleast a portion of the cap 655. The plunger 648 includes a set of sealmember 654 that can form a friction fit with an inner surface (not shownin FIG. 31) of the actuator housing 662 that defines the inner volume665 of the actuator housing 662. Thus, the plunger 648 can be configuredto divide the inner volume 665 into a first portion 667 that isfluidically isolated from a second portion 670 (also referred to hereinas “fluid reservoir”). The cap 655 defines an inlet port 658 and a setof guide post ports 659. The inlet port 658 receives a portion of afirst outlet port 624 of the diverter 620. The guide post ports 659movably receive the guide posts 607 of the housing 601 to allow theguide posts 607 to be in contact with the plunger 648. In this manner,the actuator housing 662, the plunger 648, and the cap 655 of theactuator mechanism 640 can be substantially similar to or the same asthe actuator housing 262, the plunger 248, and the cap 255,respectively, of the actuator mechanism 640 included in the transferdevice 200 described above with reference to FIGS. 2-12. Thus, aspectsof the actuator housing 662, the plunger 648, and the cap 655 are notdescribed in further detail herein. As shown in FIG. 31, the actuatormechanism 640 can differ from the actuator mechanism 240 in that theactuator mechanism 640 does not include a spring such as the spring 261of the actuator mechanism 240. In other embodiments, however, theactuator mechanism 640 can include a spring that is substantiallysimilar to the spring 261.

As shown in FIGS. 34 and 35, the diverter 620 of the transfer device 600includes a proximal end portion 628 and a distal end portion 629 anddefines an inner volume 621. The inner volume 621 can receive at least aportion of the flow control mechanism 630, as described above withreference to the transfer device 200. The proximal end portion 628 ofthe diverter 620 includes a first outlet port 624. The distal endportion 629 includes an inlet port 622 and a second outlet port 626. Thediverter 620 is movably disposed within the inner volume 611 of thehousing 601 such that a portion of the inlet port 622 extends through afirst channel 605 defined by the walls 604 of the housing 601 and aportion of the second outlet port 626 extends through a second channel605 opposite the first channel (see e.g., FIG. 30). While not explicitlyshown in FIGS. 30-41, the distal end portion 629 of the diverter 620 canengage the guide posts 607 to limit, for example, lateral movement ofthe diverter 620 as the diverter 620 is moved in the inner volume 611.Similarly stated, the guide posts 607 of the housing 601 can engage thediverter 620 to substantially limit its movement to a proximal directionor distal direction relative to the housing 601, as further describedherein.

As shown in FIG. 35, the inlet port 622, the first outlet port 624, andthe second outlet port 626 define an inlet lumen 623, a first outletlumen 625, and a second outlet lumen 627, respectively, that are each influid communication with the inner volume 621. The inlet port 622 can befluidically coupled to a needle or other lumen-containing device (notshown in FIGS. 30-41) that can be disposed within a portion of a body ofthe patient (e.g., within a vein of the patient), the first outlet port624 can be fluidically coupled to a portion of the actuator 640, and thesecond outlet port 626 can be fluidically coupled to an externalreservoir (e.g., a sample reservoir not shown in FIGS. 30-41). In thismanner, the diverter 620 can be arranged to selectively place theportion of the actuator 640 or the external reservoir in fluidcommunication with the portion of the body via the inlet port 622 andthe first outlet port 624 or via the inlet port 622 and the secondoutlet port 626, respectively. As shown in FIG. 35, the diverter 620also defines an opening 689 that can receive a portion of the flowcontrol mechanism 630, as described in further detail herein.

As shown in FIGS. 36 and 37, the flow control mechanism 630 includes afirst activation mechanism 631A, a second activation mechanism 631B, acontrol member 635, and an adjustment mechanism 685. At least a portionof the flow control mechanism 630 is configured to be disposed withinthe inner volume 621 defined by the diverter 620. More specifically, theflow control mechanism 630 has a circular cross-sectional shape suchthat when the flow control mechanism 630 is disposed in the inner volume621, a portion of the control member 635 forms a friction fit with thewalls of the diverter 620 defining the inner volume 621, as described infurther detail herein. Although not shown in FIGS. 30-41, the flowcontrol mechanism 630 can be arranged within the inner volume 611 of thehousing 601 and the inner volume 621 of the diverter 620 such that thefirst activation mechanism 631A and the second activation mechanism 631Bare disposed adjacent to and in contact with the control member 635.More specifically, the first activation mechanism 631A and the secondactivation mechanism 631B can be in frictional contact with the controlmechanism 635. In other embodiments, the first activation mechanism 631A and the second activation mechanism 631B can be coupled to the controlmember 635 via a mechanical fastener and/or an adhesive. In this manner,the first activation mechanism 631A and the second activation mechanism631B can be moved concurrently to move the control member 635, asdescribed in further detail herein.

The first activation mechanism 631A and the second activation mechanism631B include a set of engagement members 634A and 634B, respectively(although only one engagement member 634B is shown in FIG. 36, thesecond activation mechanism 631B is arranged in similar manner as thefirst activation mechanism 631A). The engagement members 634A and 634Bare configured to engage the flow control protrusion 608 of the housing601. For example, the diverter 620 and the flow control mechanism 630can be moved within the inner volume 611 of the housing 601 to place theengagement members 634A and 634B in contact with the flow controlprotrusions 608. Moreover, once the engagement members 634A and 634B areplaced in contact with the flow control protrusions 608, furthermovement of the diverter 620 and the flow control mechanism 630 canrotate the flow control mechanism 630 relative to the diverter 620between a first configuration and a second configuration, as describedin further detail herein.

As shown in FIG. 37, the control member 635 defines a first lumen 638, asecond lumen 639, and a set of channels 637. The channels 637 can beconfigured to receive a portion of the adjustment mechanism 685, asdescribed in further detail herein. The flow control mechanism 630 canbe arranged such that when in its first configuration, the first lumen638 is placed in fluid communication with the inlet lumen 623 defined bythe inlet port 622 and the first outlet lumen 625 defined by the firstoutlet port 624. Similarly, when the flow control mechanism 630 is inthe second configuration, the second lumen 639 is placed in fluidcommunication with the inlet lumen 623 defined by the inlet port 622 andthe second outlet lumen 627 defined by the second outlet port 626.Therefore, the flow control mechanism 630 can be rotated relative to thediverter 620 to selectively place the first outlet port 624 or thesecond outlet port 626 in fluid communication with the inlet port 622.

The adjustment mechanism 685 includes a dial 686 and an adjustmentmember 688 (see e.g., FIG. 31). In some embodiments, the adjustmentmember 688 can be, for example, a screw or the like. As shown in FIG.30, the adjustment mechanism 685 can be disposed adjacent to the base606 of the housing 601. More specifically, the dial 686 includes areceiving portion 686A that can be inserted into the passageway 614defined by the base 606. In this manner, a coupler 687 (e.g., aretaining ring or the like) can be positioned about the receivingportion 686 to limit movement of the dial 686 relative to the base 606.For example, the coupler 687 can be configured to limit translationalmovement of the dial 686 relative to the base 606 while allowingrotational movement of the dial 686 relative to the base 606. Theadjustment mechanism 685 can be arranged such that at least a portion ofthe adjustment member 688 is movably disposed in the opening 689 definedby the diverter 620. For example, the adjustment member 688 and a set ofwalls defining the opening 689 of the diverter 620 can define a threadedcoupling. Thus, the adjustment member 688 can be rotated relative to thediverter 620 and, as such, the adjustment member 688 can be moved in atranslation motion (e.g., proximal or distal direction) relative to thediverter 620. For example, a portion of the adjustment member 688 (e.g.,a head of a bolt or screw) can be disposed within the receiving portion686A of the dial 686 such that as the dial 686 is rotated relative tothe housing 601, the adjustment member 688 is rotated relative to thediverter 620. Moreover, a portion of the adjustment member 688 can bedisposed within one of the channels 637 of the control member 635. Assuch, the adjustment mechanism 685 can be manipulated to advance theadjustment member 688 relative to the diverter 620 to place theadjustment member 688 in contact with an engagement surface 636 of thecontrol member 635 (see e.g., FIG. 37). In this manner, the movement ofthe adjustment member 688 can exert a force on the engagement surface636 that can be sufficient to deform, bend, or otherwise reconfigure awall of the control member 635 defining either the first lumen 638 orthe second lumen 639, as described in further detail herein.

In some embodiments, the transfer device 600 can be stored in a storageconfiguration (e.g., a first configuration) in which the control member635 of the flow control mechanism 630 fluidically isolates the inletport 622, the first outlet port 624, and the second outlet port 626 fromthe inner volume 621 defined by the diverter 620. In such embodiments,first lumen 638 and the second lumen 639 are fluidically isolated fromthe inlet lumen 623, the first outlet lumen 625, and the second outletlumen 627, as shown in FIG. 38. Furthermore, the friction fit defined bythe control member 635 and the walls of the diverter 620 defining theinner volume 621 maintain the flow control mechanism 630 in the storageconfiguration until the flow control mechanism 630 is moved from thestorage configuration.

In use, a user can manipulate the transfer device 600 to couple theinlet port 622 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. The distal end portionof the lumen-defining device can be disposed within a portion of thebody of a patient (e.g., a vein), thereby placing the inlet lumen 623 influid communication with the portion of the body of the patient. In asimilar manner, the second outlet port 626 can be coupled to an externalfluid reservoir (not shown). The external fluid reservoir can be anysuitable reservoir. For example, in some embodiments, the external fluidreservoir can be a BacT/ALERT® SN or a BacT/ALERT® FA, manufactured byBIOMERIEUX, INC.

With the inlet port 622 coupled to the lumen-defining device and thesecond outlet port 626 coupled to the external fluid reservoir, a usercan move the transfer device 600 from the first configuration to asecond configuration by applying an activation force to the actuatormechanism 640. In this manner, at least a portion of the actuatormechanism 640, the diverter 620, and the flow control mechanism 630 aremoved in the distal direction toward the second configuration, asindicated by the arrow WW in FIG. 39. More specifically and as describedabove, the arrangement of the plunger 648 and the guide posts 607 issuch that as the user applies the activation force to the actuatormechanism 640, the position of the plunger 648, relative to the housing601, is maintained. Therefore, the activation force applied by the usermoves the actuator housing 662, the cap 655, the diverter 620, and theflow control mechanism 630 in the direction of the arrow WW, but not theplunger 648. The distal movement of the actuator housing 662 is suchthat the height of the first portion 667 of the inner volume 665 isreduced and the height of the fluid reservoir 670 is increased. With thefluid reservoir 670 being fluidically isolated (as described above) theincrease in the height (i.e., the increase in volume) produces anegative pressure within the fluid reservoir 670. Said another way, themovement of the plunger 648 increases the volume of the fluid reservoir670, which, in turn, produces a negative pressure therein.

As the actuator mechanism 640 is moved from the storage configurationtoward the first configuration, the flow control protrusions 608 engagethe engagement members 634A and 634B of the first activation mechanism631A and the second activation member 631B, respectively, (not shown inFIG. 39) to move the flow control mechanism 630 toward the firstconfiguration, as indicated by the arrow XX in FIG. 39. Thus, when theflow control mechanism 630 is moved to its first configuration, thefirst lumen 638 defined by the control member 635 is placed in fluidcommunication with the inlet lumen 623 defined by the inlet port 622 andthe first outlet lumen 625 defined by the first outlet port 624. Asindicated by the arrow YY in FIG. 39, the inlet lumen 623 of the inletport 622, the first lumen 638 of the control member 635, and the firstoutlet lumen 625 of the first outlet port 624 define a fluid flow pathsuch that the fluid reservoir 670 defined by the actuator housing 662 isplaced in fluid communication with the inlet port 622. Thus, thenegative pressure within the fluid reservoir 670 is such that thenegative pressure differential introduces a suction force within theportion of the patient. In this manner, a bodily-fluid is drawn into thefluid reservoir 670 of the actuator housing 662, as indicated by thearrow YY. In some embodiments, the bodily-fluid can contain undesirablemicrobes such as, for example, dermally-residing microbes. In someinstances, the magnitude of the suction force can be modulated byincreasing or decreasing the amount of activation force applied to theactuator mechanism 640. In this manner, the change in the volume of thefluid reservoir 670 can be modulated such that a desired amount of asuction force is exerted within the vein of the patient.

With the desired amount of bodily-fluid transferred to the fluidreservoir 670 defined by the actuator housing 662, a user can manipulatethe transfer device 600 to move the transfer device 600 from the secondconfiguration to the third configuration, wherein a flow of bodily-fluidis transferred to the external reservoir (e.g., such as those describedabove). In some embodiments, the desired amount of bodily-fluidtransferred to the actuator housing 662 is a predetermined amount offluid, as described in detail above.

The transfer device 600 can be moved from the second configuration tothe third configuration by further moving the actuator mechanism 640 inthe distal direction, as indicated by the arrow ZZ in FIG. 40. Expandingfurther, the user can apply an activation force to the actuatormechanism 640 such that the actuator housing 662, the cap 655, thediverter 620, and the flow control mechanism 630 move in the distaldirection. With the desired amount of the bodily-fluid disposed withinthe fluid reservoir 670 the volume of the fluid reservoir 670 isconfigured to remain constant as the actuator housing 662 and the cap655 move relative to the plunger 648. Similarly stated, the pressure ofthe fluid reservoir 670 is configured to remain substantially unchangedas the transfer device 600 is moved from the first configuration to thesecond configuration. As the actuator mechanism 640 is moved from itsfirst configuration toward its second configuration, the flow controlprotrusions 608 engage the engagement members 634A and 634B to rotatethe flow control mechanism 630 toward the second configuration, asindicated by the arrow AAA. Thus, when the flow control mechanism 630 ismoved to its second configuration, the second lumen 639 defined by thecontrol member 635 is placed in fluid communication with the inlet lumen623 defined by the inlet port 622 and the second outlet lumen 627defined by the second outlet port 626.

As shown by the arrow BBB, the inlet lumen 623 of the inlet port 622,the second lumen 639 of the control member 635, and the second outletlumen 627 of the second outlet port 626 define a fluid flow path suchthat the external reservoir (not shown in FIG. 40) is in fluidcommunication with the inlet port 622 and, therefore, the portion of thepatient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid canbe drawn into the external reservoir that is fluidically isolated fromthe first, predetermined amount of bodily-fluid contained within thefluid reservoir 670 defined by the actuator housing 662. In this manner,the bodily-fluid contained in the external reservoir is substantiallyfree from microbes generally found outside of the portion of the patient(e.g., dermally residing microbes, microbes within a lumen defined bythe transfer device 600, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe).

In some instances, it may be desirable to limit and/or modulate theamount of a suction force exerted on the vein of the patient and/or aflow rate of the bodily-fluid. In such instances, the user canmanipulate the adjustment mechanism 685 to move the adjustment member688 relative to the control member 635. For example, the distal movementof the diverter 620 relative to the housing 601 is such that a portionof the adjustment member 688 is disposed in the receiving portion 686Aof the dial 686. In this manner, the dial 686 can be rotated to advancethe adjustment member 688 relative to the control member 635, asindicated by the arrow CCC in FIG. 41. Thus, the adjustment member 688can be moved into contact with the engagement surface 636 to deform aportion of the control member 635 defining the second lumen 639. Assuch, the wall of the control member 635 constricts the second lumen 639(e.g., reduces a diameter of at least a portion of the second lumen639), thereby reducing the suction force exerted within the vein and/orslowing the rate at which the bodily-fluid flows within the second lumen639. In some embodiments, the dial 686 can be rotated in alternatingdirections to alternately move the adjustment member 688 in the proximaldirection and the distal direction. In this manner, the flow of thebodily-fluid can be, for example, pulsed or the like. In this manner,bodily-fluid that is substantially free from microbes (e.g., dermallyresiding microbes or the like) can flow with a desired set ofcharacteristics into the external reservoir.

While the transfer device 200 is described above with reference to FIGS.2-12 as including a linear spring 261 (e.g., a compression spring), inother embodiments, a transfer device can include any suitable springthat can be configured to modulate, change, and/or control a negativepressure within a fluid reservoir and/or a flow rate of a bodily-fluid.For example, FIGS. 42-47 illustrate a transfer device 700 according toanother embodiment. The transfer device 700 includes a housing 701, adiverter 720, a flow control mechanism 730, and adjustment mechanism785, and an actuator 740. The transfer device 700 can be any suitableshape, size, or configuration. For example, portions of the transferdevice 700 can be substantially similar to or the same as correspondingportions of the transfer device 200 (described above with reference toFIGS. 2-12) and/or the transfer device 600 (described above withreference to FIGS. 30-41). As such, aspects of the transfer device 700of the transfer device 700 are not described in further detail herein.

The housing 701 of the transfer device 700 includes a proximal endportion 702 and a distal end portion 703. The distal end portion 703includes a base 706 from which a set of walls 704 extend. The walls 704of the housing 701 define a substantially annular shape and define aninner volume 711 between the proximal end portion 702 and the distal endportion 703. The proximal end portion 702 of the housing 701 is open toreceive at least a portion of the diverter 720, a portion of the flowcontrol mechanism 730, and a portion of the actuator 740 within theinner volume 711 (see e.g., FIG. 31). The walls 704 of the housing 701define a set of status windows 710 and a set of channels 705. The statuswindows 710 and the channels 705 can be any suitable shape or size. Forexample, the status windows 710 and the channels 705 can besubstantially similar in form and function to the status windows 210 andthe channels 205 of the transfer device 200. The housing 701 includes aset of guide posts 707 and a set of flow control protrusions (not shownin FIGS. 43-46). In this manner, the housing 701 can function similarlyto the housing 601 included in the transfer device 600 described above.

As shown in FIG. 31, the actuator mechanism 740 includes the actuatorhousing 762, a plunger 748, and a cap 755. The actuator mechanism 740 isconfigured to move between a first configuration and a secondconfiguration, thereby moving the transfer device 700 between a firstconfiguration and a second configuration, as described in further detailherein. The actuator housing 762 includes a proximal end portion 763 anda distal end portion 764 and defines an inner volume 765. The innervolume 765 of the actuator housing 762 receives the plunger 748 and atleast a portion of the cap 755. As such, the actuator mechanism 740 canbe substantially similar in form and function as the actuator mechanism640 included in the transfer device 600 described above with referenceto FIGS. 30-41. Thus, the plunger 748 can be disposed in the actuatorhousing 762 to divide the inner volume 765 into a first portion 767 anda second portion 770 (also referred to herein as “fluid reservoir”).

As shown in FIGS. 43, the diverter 720 of the transfer device 700includes an inlet port 722, a first outlet port 724, and a second outletport 726 and defines an inner volume 721. The inner volume 721 canreceive at least a portion of the flow control mechanism 730, asdescribed above with reference to the transfer device 200. The diverter720 is movably disposed within the inner volume 711 of the housing 701such that a portion of the inlet port 722 extends through a firstchannel 705 defined by the walls 704 of the housing 701 and a portion ofthe second outlet port 726 extends through a second channel 705 oppositethe first channel (see e.g., FIG. 42). While not explicitly shown inFIGS. 42-46, the distal end portion 729 of the diverter 720 can engagethe guide posts 707 to limit, for example, lateral movement of thediverter 720 as the diverter 720 is moved in the inner volume 711.Similarly stated, the guide posts 707 of the housing 701 can engage thediverter 720 to substantially limit its movement to a proximal directionor distal direction relative to the housing 701, as further describedherein.

The inlet port 722, the first outlet port 724, and the second outletport 726 define an inlet lumen 723, a first outlet lumen 725, and asecond outlet lumen 727, respectively, that are each in fluidcommunication with the inner volume 721 (see e.g., FIGS. 45 and 46). Theinlet port 722 can be fluidically coupled to a needle or otherlumen-containing device (not shown in FIGS. 30-41) that can be disposedwithin a portion of a body of the patient (e.g., within a vein of thepatient), the first outlet port 724 can be fluidically coupled to aportion of the actuator 740, and the second outlet port 726 can befluidically coupled to an external reservoir (e.g., a sample reservoirnot shown in FIGS. 30-41). In this manner, the diverter 720 can bearranged to selectively place the portion of the actuator 740 or theexternal reservoir in fluid communication with the portion of the bodyvia the inlet port 722 and the first outlet port 724 or via the inletport 722 and the second outlet port 726, respectively.

As shown in FIG. 44, the flow control mechanism 730 includes a firstactivation mechanism 731A, a second activation mechanism 731B, a controlmember 735, a first torsion spring 761A, and a second torsion spring761B. At least a portion of the flow control mechanism 730 is configuredto be disposed within the inner volume 721 defined by the diverter 720,as described above. Although not shown in FIGS. 42-46, the flow controlmechanism 730 can be arranged within the inner volume 711 of the housing701 and the inner volume 721 of the diverter 720 such that the firstactivation mechanism 731A and the second activation mechanism 731B aredisposed adjacent to and in contact with the control member 735. Morespecifically, the first activation mechanism 731A and the secondactivation mechanism 731B can be in frictional contact with the controlmechanism 735. In other embodiments, the first activation mechanism 731Aand the second activation mechanism 731B can be coupled to the controlmember 735 via a mechanical fastener and/or an adhesive. In this manner,the first activation mechanism 731A and the second activation mechanism731B can be moved concurrently to move the control member 735, asdescribed in further detail herein.

The first activation mechanism 731A and the second activation mechanism731B include a set of engagement members 734A and 734B, respectively(although only one engagement member 734B is shown in FIG. 36, thesecond activation mechanism 731B is arranged in similar manner as thefirst activation mechanism 731A). The engagement members 734A and 734Bare configured to engage the flow control protrusion 708 of the housing701, as described with reference to the transfer device 600 of FIGS.30-41. In use, once the engagement members 734A and 734B are placed incontact with the flow control protrusions 708, further movement of thediverter 720 and the flow control mechanism 730 can rotate the flowcontrol mechanism 730 relative to the diverter 720 between a firstconfiguration and a second configuration. As such, the torsion springs761A and 761B can be moved from a first configuration having asubstantially smaller potential energy to a second configuration havinga substantially larger potential energy. In other words, the rotationalmovement of the flow control mechanism 730 relative to the diverter 720can transfer the torsion springs 761A and 761B to a configuration havinga larger potential energy than the potential energy prior to therotation of the flow control mechanism 730 relative to the diverter 720,as described in further detail herein.

As shown in FIG. 44, the control member 735 defines a first lumen 738, asecond lumen 739. The flow control mechanism 730 can be arranged suchthat when in its first configuration, the first lumen 738 is placed influid communication with the inlet lumen 723 defined by the inlet port722 and the first outlet lumen 725 defined by the first outlet port 724.Similarly, when the flow control mechanism 730 is in the secondconfiguration, the second lumen 739 is placed in fluid communicationwith the inlet lumen 723 defined by the inlet port 722 and the secondoutlet lumen 727 defined by the second outlet port 726. Therefore, theflow control mechanism 730 can be rotated relative to the diverter 720to selectively place the first outlet port 724 or the second outlet port726 in fluid communication with the inlet port 722.

In some embodiments, the transfer device 700 can be stored in a storageconfiguration in which the control member 735 of the flow controlmechanism 730 fluidically isolates the inlet port 722, the first outletport 724, and the second outlet port 726 from the inner volume 721defined by the diverter 720. In such embodiments, first lumen 738 andthe second lumen 739 are fluidically isolated from the inlet lumen 723,the first outlet lumen 725, and the second outlet lumen 727.Furthermore, the friction fit defined by the control member 735 and thewalls of the diverter 720 defining the inner volume 721 maintain theflow control mechanism 730 in the storage configuration until the flowcontrol mechanism 730 is moved from the storage configuration.

In use, a user can manipulate the transfer device 700 to couple theinlet port 722 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. The distal end portionof the lumen-defining device can be disposed within a portion of thebody of a patient (e.g., a vein), thereby placing the inlet lumen 723 influid communication with the portion of the body of the patient. In asimilar manner, the second outlet port 726 can be coupled to an externalfluid reservoir (not shown). The external fluid reservoir can be anysuitable reservoir. For example, in some embodiments, the external fluidreservoir can be a BacT/ALERT® SN or a BacT/ALERT® FA, manufactured byBIOMERIEUX, INC.

With the inlet port 722 coupled to the lumen-defining device and thesecond outlet port 726 coupled to the external fluid reservoir, a usercan move the transfer device 700 from the first configuration to asecond configuration by applying an activation force to the actuatormechanism 740. In this manner, at least a portion of the actuatormechanism 740, the diverter 720, and the flow control mechanism 730 aremoved in the distal direction toward the second configuration, asindicated by the arrow DDD in FIG. 45. More specifically and asdescribed above, the distal movement of the actuator housing 762 is suchthat a height of the first portion 767 of the inner volume 765 isreduced and a height of the fluid reservoir 770 is increased. With thefluid reservoir 770 being fluidically isolated (as described above) theincrease in the height (i.e., the increase in volume) produces anegative pressure within the fluid reservoir 770. Said another way, themovement of the plunger 748 increases the volume of the fluid reservoir770, which, in turn, produces a negative pressure therein.

As shown in FIG. 45, when the flow control mechanism 730 is moved to itsfirst configuration (e.g., from a storage configuration), the firstlumen 738 defined by the control member 735 is placed in fluidcommunication with the inlet lumen 723 defined by the inlet port 722 andthe first outlet lumen 725 defined by the first outlet port 724. Asindicated by the arrow EEE in FIG. 45, the inlet lumen 723 of the inletport 722, the first lumen 738 of the control member 735, and the firstoutlet lumen 725 of the first outlet port 724 define a fluid flow pathsuch that the fluid reservoir 770 defined by the actuator housing 762 isplaced in fluid communication with the inlet port 722. Thus, thenegative pressure within the fluid reservoir 770 is such that thenegative pressure differential introduces a suction force within theportion of the patient. In this manner, a bodily-fluid is drawn into thefluid reservoir 770 of the actuator housing 762, as indicated by thearrow EEE. In some embodiments, the bodily-fluid can contain undesirablemicrobes such as, for example, dermally-residing microbes.

In some instances, the magnitude of the suction force can be modulatedby increasing or decreasing the amount of activation force applied tothe actuator mechanism 740. More specifically and as described above,the rotational movement of the flow control mechanism 730 can increasethe potential energy of the torsion springs 761A and 761B (not shown inFIG. 45). For example, in some embodiments, an end portion of thetorsion springs 761A and 761B can be placed in contact with the flowcontrol protrusions 708 to substantially limit the movement of the endportion of the torsion springs 761A and 761B. Thus, the rotationalmovement of the first activation mechanism 731A and the secondactivation mechanism 731B rotates a second end portion of the torsionsprings 761A and 761B, respectively, relative to the end portion incontact with the flow control protrusions 708, thereby changing thepotential energy of the torsion springs 761A and 761B. In this manner,the torsion springs 761A and 761B can exert a reaction force that canresist the activation force applied to the user on the actuatormechanism 740. Therefore, by reducing the activation force, the flowcontrol mechanism 730 can rotate relative to the diverter 720 to changethe alignment of the first lumen 738 of the control member 735 relativeto the inlet lumen 723 and the first outlet lumen 725 of the diverter720. As such, the negative pressure within the fluid reservoir 770 canbe reduced and/or otherwise changed.

With the desired amount of bodily-fluid transferred to the fluidreservoir 770 defined by the actuator housing 762, a user can manipulatethe transfer device 700 to move the transfer device 700 from the secondconfiguration to the third configuration, wherein a flow of bodily-fluidis transferred to the external reservoir (e.g., such as those describedabove). In some embodiments, the desired amount of bodily-fluidtransferred to the actuator housing 762 is a predetermined amount offluid, as described in detail above. The transfer device 700 can bemoved from the first configuration to the second configuration byfurther moving the actuator mechanism 740 in the distal direction, asindicated by the arrow FFF in FIG. 46. Expanding further, the user canapply an activation force to the actuator mechanism 740 such that theactuator housing 762, the cap 755, the diverter 720, and the flowcontrol mechanism 730 move in the distal direction. As the actuatormechanism 740 is moved from its first configuration toward its secondconfiguration, the flow control protrusions 708 engage the engagementmembers 734A and 734B to rotate the flow control mechanism 730 towardthe second configuration, as indicated by the arrow GGG. Thus, when theflow control mechanism 730 is moved to its second configuration, thesecond lumen 739 defined by the control member 735 is placed in fluidcommunication with the inlet lumen 723 defined by the inlet port 722 andthe second outlet lumen 727 defined by the second outlet port 726.

As shown by the arrow HHH in FIG. 46, the inlet lumen 723 of the inletport 722, the second lumen 739 of the control member 735, and the secondoutlet lumen 727 of the second outlet port 726 define a fluid flow pathsuch that the external reservoir (not shown in FIG. 46) is in fluidcommunication with the inlet port 722 and, therefore, the portion of thepatient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid canbe drawn into the external reservoir that is fluidically isolated fromthe first, predetermined amount of bodily-fluid contained within thefluid reservoir 770 defined by the actuator housing 762. In this manner,the bodily-fluid contained in the external reservoir is substantiallyfree from microbes generally found outside of the portion of the patient(e.g., dermally residing microbes, microbes within a lumen defined bythe transfer device 700, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe).

In some instances, it may be desirable to limit and/or modulate theamount of a suction force exerted on the vein of the patient and/or aflow rate of the bodily-fluid. In such instances, the user can decreasethe activation force applied to the actuator mechanism 740. In thismanner, the torsion springs 761A and 761B can exert a force that isoperable in rotating the control member 735 relative to the diverter720. Thus, the flow control mechanism 730 can rotate relative to thediverter 720 to change the alignment of the first lumen 738 of thecontrol member 735 relative to the inlet lumen 723 and the first outletlumen 725 of the diverter 720. As such, the negative pressure within thefluid reservoir 770 can be reduced, modulated, pulsed and/or otherwisechanged.

Referring now to FIG. 47, a flowchart illustrates a method 1000 forparenterally procuring a bodily-fluid sample that is substantially freefrom microbes. In some embodiments, the method 1000 includes inserting aneedle of a parenteral sampling device into a patient, at 1001. In someembodiments, the parenteral sampling device can be, for example, a fluidtransfer device such as those described herein. As such, the parenteralsampling device (also referred to herein as “device”) can include atleast the needle, an actuator, a flow control mechanism, and a fluidreservoir. As described above with reference to the transfer devices100, 200, 300, 400, 500, 600, and/or 700, the device can be configuredto selectively place the needle in fluid communication with the fluidreservoir.

The method 1000 includes establishing fluid communication between theneedle and the fluid reservoir, at 1002. For example, in someembodiments, the device can be in a storage configuration prior to usein which the needle is fluidically isolated from the fluid reservoir.Therefore, in use, the device can be manipulated to define a fluid flowpath between the needle and the fluid reservoir. In some embodiments,for example, the device can be manipulated to arrange the flow controlmechanism included in the device in a first configuration such that theflow control mechanism defines at least a portion of the fluid flowpath. For example, the flow control mechanism can be substantiallysimilar to the flow control mechanism 230 included in the transferdevice 200 described above with reference to FIGS. 2-12.

With the flow path defined between the needle and the fluid reservoir,an actuator is moved a first distance to create a negative pressure inthe fluid reservoir and to withdraw a predetermined volume ofbodily-fluid, at 1003. For example, in some embodiments, a user canexert an activation force on the actuator to move the actuator relativeto a portion of the device. In such embodiments, the actuator caninclude a plunger or the like that can be disposed within a portion ofthe actuator and arranged such that the plunger defines, at leastpartially, the fluid reservoir. Thus, when the activation force isapplied to the actuator, the actuator can move relative to the plungersuch that a negative pressure is produced within the fluid reservoir. Inthis manner, a bodily-fluid can flow through a first flow path from theneedle to the fluid reservoir (e.g., via a lumen defined by the flowcontrol mechanism). In some instances, the negative pressure in thefluid reservoir can be reduced, for example, by reducing the activationforce applied to the actuator and/or releasing the actuator, at 1004.For example, in some embodiments, the actuator can include a springand/or any other suitable device, mechanism, or member that can beoperable in constricting at least a portion of the fluid flow path. Thenegative pressure in a subsequent sample reservoir can also be reduced,for example, by apply an activation force to the actuator, at 1004, asdescribed herein.

The method 1000 includes moving the actuator a second distance to engagethe flow control mechanism to move the flow control mechanism betweenthe first configuration and a second configuration that is operable inallowing bodily-fluid to flow through a second flow path from the needleto a sample reservoir, at 1005. For example, in some embodiments, bymoving the actuator the second distance, the flow control mechanism isrotated such that a lumen defined therein defines at least a portion ofthe second fluid flow path. In this manner, bodily-fluid can flowthrough the second flow path to be disposed within the sample reservoir.In some embodiments, the collection and/or the isolation of a firstvolume of the bodily-fluid can reduce and/or eliminate, for example, anamount of microbes (e.g., dermally-residing microbes, other undesirableexternal contaminants, or the like) in the sample volume.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods and steps described above indicate certainevents occurring in certain order, those of ordinary skill in the arthaving the benefit of this disclosure would recognize that the orderingof certain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Additionally, certain steps may be partially completed and/or omittedbefore proceeding to subsequent steps.

While various embodiments have been particularly shown and described,various changes in form and details may be made. Although variousembodiments have been described as having particular features and/orcombinations of components, other embodiments are possible having anycombination or sub-combination of any features and/or components fromany of the embodiments described herein. For example, while the notshown in FIGS. 28 and 29, in some embodiments, the transfer device 500can include a throttling button, similar in form and function to thethrottling button 445 included in the transfer device 400. By way ofanother example, although not shown in FIGS. 30-41, in some embodiments,the transfer device 600 can include one or more springs such as, forexample, the spring 261 of the transfer device and/or the torsionsprings 761A and 761B of the transfer device 700.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily-fluid flow into a fluid reservoir.

1.-39. (canceled)
 40. A blood transfer system, comprising: an access device at least partially insertable into a patient; a first tubing fluidically coupleable to the access device; a transfer device having an inlet port fluidically coupled to the first tubing, the transfer device having a seal member disposed at an end portion of a first fluid flow path and at least partially defining an inner volume, the inner volume receiving a first volume of blood flowing through the first fluid flow path toward the seal member when the transfer device is in a first state, the transfer device allowing a second volume of blood to flow from the inlet port via a second fluid flow path toward an outlet port while bypassing the inner volume when the transfer device is in a second state; and a second tubing fluidically coupleable to a sample reservoir external to the transfer device, the second volume of blood flowing from the second fluid flow path into the second tubing when the transfer device is in the second state.
 41. The blood transfer system of claim 40, wherein the inlet port defines a lumen, the lumen defining a first portion of the first fluid flow path when the transfer device is in the first state and a first portion of the second fluid flow path when the transfer device is in the second state.
 42. The blood transfer system of claim 41, wherein the second volume of blood flows past a second portion of the first fluid flow path when the transfer device is in the second state.
 43. The blood transfer system of claim 40, wherein the access device is a needle, the first volume of blood is at least equal to a volume of a lumen of the needle.
 44. The blood transfer system of claim 40, wherein the access device is an indwelling catheter, the first volume of blood is at least equal to a volume of a lumen of the catheter.
 45. The blood transfer system of claim 40, wherein the transfer device transitions from the first state to the second state without manual intervention.
 46. The blood transfer system of claim 40, wherein the transfer device automatically transitions from the first state to the second state when the first volume of blood substantially fills the inner volume.
 47. The blood transfer system of claim 46, wherein the transfer device retains the first volume of blood in the inner volume when the transfer device is in the second state.
 48. The blood transfer system of claim 40, wherein the transfer device automatically changes blood flow from flowing through the first flow path to flowing through the second flow path when the first volume of blood substantially fills the inner volume.
 49. The blood transfer system of claim 48, wherein the transfer device retains the first volume of blood in the inner volume when the transfer device is in the second state.
 50. The blood transfer system of claim 40, wherein the seal member forms a fluidic seal with at least one wall of the transfer device to define a portion of the inner volume.
 51. The blood transfer system of claim 40, wherein the seal member transitions the transfer device from the first state to the second state, the transfer device allowing a pressure differential as the seal member transitions the transfer device between the first state and the second state.
 52. The blood transfer system of claim 51, wherein the transfer device is in the second state when the pressure differential equalizes.
 53. The blood transfer system of claim 40, wherein the outlet port is fluidically coupled to the second tubing.
 54. The blood transfer system of claim 40, wherein the outlet port is disposed at an end portion of the second fluid flow path, the second volume of blood flows from the second fluid flow path into the second tubing when the transfer device is in the second state and the second tubing is fluidically coupled to the outlet port of the transfer device. 